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chrisoco

Guest
What is the name of your state? Ohio

Last year (13 months ago) I was seen in an EMD for a bloody nose that wouldn't stop. I have no history of bloody noses though I've had a few here and there over time. This was very unreal. It came on out of nowhere, tookforever to control and then started up again the next day with no relief. I spent over an hour with my nose pinched in the EMD and yet it still trickled a line of blood when the pressure was released.

A "Rapid Rhino" device was placed in my nose. My husband, a medic, was present at the time. The bulb in the device was inflted with 20ml of air. The doctor verbalized this and my husband witnessed it. I nearly went insane. The pressure was unreal. I could not swallow, was in immense pain, and dispite major pain relief meds, I could not sleep. I was told to return to the EMD after 24 hours but I went back after only 17 hours and demanded it be removed. They did so and no blood. I was relieved but then I started leaking a clear fluid. I was told it was from minor damage to the surrounding tissue and to be expected. The next day, I was still leaking. I went to my general practicioner who ordered me to the hospital for a CAT scan. It seems the device was only to be inflated with only 5-7ml of air. My scan came out clear and two days later, the leaking stopped. While healing took awhile, I didn't think I had any complications of the ordeal.

So here I am a year later and I've started noticing problems. I have almost constant sinus pressure, frequent eye pain on that side of my face and when traveling in hills and valleys as the pressure changes (like where your ear pops) I can hardly stand the pain. When I blow my nose, it is almost always tingued with blood and even slight bumps cause a nose bleed now. It was only in May that I traveled through hills and valleys and first noticed the problem. It was then that I put it together with the event last summer. I started realizing that it has been constant since that time.

I mentioned the sinus pressure problems to my doctor but that was before I connected things.

Do I have a case I should move forward with? What do I do to establish a problem? I know for certain that the doctor improperly used the device but without a bunch of tests, all I have is a gut feeling that there is some damage there. Am I stuck since its been so long?

Chris O'Connor
 


rmet4nzkx

Senior Member
I did a search on this device and discovered there are 3 different manufactors of this device which is fairly new on the market and depending on the model the pressure you quote is within limits for the inflated models, so if you were told it was overinflated there may be some confusion between that and another model, also the amount of testing required for the new devices. There have been some problems with these devices which are FDA approved. If you consult with an attorney they can advise of the statute of limitations.

If you have a case, it may be against the maker of the product, the doctor, hospital but proving it is going to be a problem depending on which one was used, if and or why there was confusion or was the package marked incorrectly, was it an individual reaction etc.

While you state you don't have a history of nose bleeds, you then state you have had them over the years off and on.

What you describe is a significant nose bleed, were you tested for bleeding disorders? Do you have a history of abnormal digns of bleeding? gums bleed at times, easy bruising, etc? While we think of men having bleeding disorders there are several disorders that women also get and may be difficult to diagnoise because lab tests may not always show the problem when you are actively bleeding. Ask your doctor for a referal to a hemotologist for evaluation for bleeding disorders. If you have one, they may be successfully treated treated so finding that out now may be a blessing and avoid similar problems in the future.

Was the clear fluid tested? Prior to the nose bleed have you had any head injuries or blows to the head, if so, how long hours, days, weeks, months, years? Were you on any medications or have you had any adverse drug reactions? What was the CAT scan ordered to diagnoise? If the slices were too thick, some forms of skull fractures cannot be detected. Answer to these questions might help determine what type of case you have, if any and also if your unique medical profile contributed to your reaction.
 
R

RandallFabiano

Guest
rmet are you serious.???

First off, if you consented to the proceedure and it was performed flawless and you were informed of risks, success is not required. Meaning you have no case regardless of the outcome. You have to prove that the use of this device was outside the standard of care or absent consent. Even then it may be deemed erroneous. On the hospital paper you probably signed on entry it said if you have a claim, all claims shall be solved by binding arbitration. Most hospitals have it, and therefore, your ability to collect may be a bit hard.

“While a physician cannot be held liable for mere errors of judgment
or for erroneous conclusions on matters of opinion, he must use the
judgment and form the opinions of one possessed of knowledge and
skill common to medical men practicing, in the same or like
community and that he may have done his best is no answer to an
action of this sort.” (Sim v. Weeks (1935) 7 Cal.App.2d 28, 36 [45
P.2d 350].)
“The ‘law has never held a physician or surgeon liable for every
untoward result which may occur in medical practice’ but it ‘demands
only that a physician or surgeon have the degree of learning and skill
ordinarily possessed by practitioners of the medical profession in the
same locality and that he exercise ordinary care in applying such
learning and skill to the treatment of his patient.’ ” (Huffman v.
Lindquist (1951) 37 Cal.2d 465, 473 [234 P.2d 34] [internal citations
omitted].)

Dincau v. Tamayose (1982) 131 Cal.App.3d 780, 800 [182 Cal.Rptr.
855].)
c “[A] physician and surgeon is not required to make a perfect diagnosis
but is only required to have that degree of skill and learning ordinarily
possessed by physicians of good standing practicing in the same
locality and to use ordinary care and diligence in applying that learning
to the treatment of his patient.” (Ries v. Reinard (1941) 47 Cal.App.2d
116, 119 [117 P.2d 386].)
“A doctor is not a warrantor of cures nor is he required to guarantee
results and in the absence of a want of reasonable care and skill will
not be held responsible for untoward results.” (Sanchez v. Rodriguez
(1964) 226 Cal.App.2d 439, 449 [38 Cal.Rptr. 110].)
 

ellencee

Senior Member
Oh, my goodness, I am about to scream loud enough for the two of you to hear me wherever you may be.

rmet4nzkx
I like you and your contributions, so please take this within the context of changes in all of us (including me) since Randy-the-nitwit showed up. EC

OP, et al
The first element in a medmal suit is the MEDICAL aspect. If you can't prove the medical aspect, the legal aspect is meaningless.

As RM stated, the inflation level will have to ascertained according to product type and then, guess what, to the physician's judgment of what was needed to stop the bleeding.

If damages resulted from the pressure of the tube, so what? The patient was not responding to less aggressive treatment and was bleeding excessively. True, those devices are impossibly uncomfortable but what would a reasonable person expect from a balloon being blown up inside one's nose?

The patient and physician had two choices: let the patient bleed to death or insert an inflatable device that would exert pressure on the surrounding tissues, probably damaging some tissue but stopping the bleeding. What choice would a reasonable person make?

chrisoco
Consult with a medmal attorney in your area in the near future so that if any causes of action exists, you will protect the statute of limitations that may apply. Then, or before, consult with an ENT specializing in trauma and have that ENT rule in or rule out problems brought on by trauma (not necessarily from medmal, just trauma).

EC
 
C

chrisoco

Guest
rmet4nzkx said:
I did a search on this device and discovered there are 3 different manufactors of this device which is fairly new on the market and depending on the model the pressure you quote is within limits for the inflated models, so if you were told it was overinflated there may be some confusion between that and another model, ...

I wasn't aware of that (several models). My husband contacted the manufacturer based on the product info the doc gave him in the EMD. Remember, my husband is a medic and asked lots of questions, and chit chatted with the doc through most of my stay. In fact, this doc was really super and that's why, when I found out there may be a problem, I was reluctant to go suing everyone everywhere. What happened in the short term felt like it was within the normal boundaries of a medical proceedure, what can go wrong, and a minor mistake. I didn't want to make a grand case of things. It is only as I fear something else may be wrong that I'm wondering about securing care to fix it.​

If you have a case, it may be against the maker of the product, the doctor, hospital but proving it is going to be a problem depending on which one was used, if and or why there was confusion or was the package marked incorrectly, was it an individual reaction etc.

Point well made, thank you.​

While you state you don't have a history of nose bleeds, you then state you have had them over the years off and on.

Ahh.. I read this over this morning and wondered if I wasn't clear. I mean surely, I've taken a bouncing ball to the face as a child and had a nosebleed. I've also had them after taking antihistamines during winter cold season. And I've gone to itch inside my nose and caused it to bleed before. We're talking less than one per year and all easily stopped. I don't consider that a "history", just a normal incidence. Hope that clarifies.​

What you describe is a significant nose bleed, were you tested for bleeding disorders? Do you have a history of abnormal digns of bleeding? gums bleed at times, easy bruising, etc?

Well worth noting, and yes. In the EMD and again at my general practicianers's office, I was tested for various bleeding disorders - all negative. It was certainly a concern about why this happened.​

Was the clear fluid tested?

yes, it was CS fluid.​

Prior to the nose bleed have you had any head injuries or blows to the head, if so, how long hours, days, weeks, months, years? Were you on any medications or have you had any adverse drug reactions?

No head injuries in the last 17 years. I was in a major car accident 17 years ago but sustained no major head injuries. I had had a cold/summer alergy problem and had been taking a decongestant and expectorant. But I had stopped a few days prior to this event. I had taken Excedrine about 2 hours prior to the first episode and I did bump my nose with my hand as I reached to stop a glass from falling just seconds before the bleeding began the first time. It took 45 mins to stop. 15 hours later, the next day, is when the one began spontaniously that ended up with me transported to the EMD.​

What was the CAT scan ordered to diagnoise?

My doctor believed I may have fractured the small bone at the top of my nose (can't recall the name of it right now). She also worried about damage to my eye socket.​

If the slices were too thick, some forms of skull fractures cannot be detected. Answer to these questions might help determine what type of case you have, if any and also if your unique medical profile contributed to your reaction.
Sounds like I need to start with getting my records and talking with my regular doctor about what exactly were her concerns and the details of the test results. Then on to a medmal attorney as EC directed. Do you think I should request my medical records from this EMD? Should I talk with the attorney first? :) Thinking out loud, sorry.

Thank you for a considerate reply,

Chris O'Connor
 

rmet4nzkx

Senior Member
ellencee said:
Oh, my goodness, I am about to scream loud enough for the two of you to hear me wherever you may be. LOL me too! RF can't even stay on his own page with all this stuff about consent.

rmet4nzkx
I like you and your contributions, so please take this within the context of changes in all of us (including me) since Randy-the-nitwit showed up. EC
Thank You, it was taken in the proper context.
OP, et al
The first element in a medmal suit is the MEDICAL aspect. If you can't prove the medical aspect, the legal aspect is meaningless.

As RM stated, the inflation level will have to ascertained according to product type and then, guess what, to the physician's judgment of what was needed to stop the bleeding. The only possiblity I saw was for product liability, malfunction as pressure was WNL, if everything is as stated.

If damages resulted from the pressure of the tube, so what? The patient was not responding to less aggressive treatment and was bleeding excessively. True, those devices are impossibly uncomfortable but what would a reasonable person expect from a balloon being blown up inside one's nose?

The patient and physician had two choices: let the patient bleed to death or insert an inflatable device that would exert pressure on the surrounding tissues, probably damaging some tissue but stopping the bleeding. What choice would a reasonable person make?

chrisoco
Consult with a medmal attorney in your area in the near future so that if any causes of action exists, you will protect the statute of limitations that may apply. Then, or before, consult with an ENT specializing in trauma and have that ENT rule in or rule out problems brought on by trauma (not necessarily from medmal, just trauma).

EC
and don't forget the hematologist, because if there is a bleeding disorder an infusion might do the trick next time, also some aspects of your medical history might affect treatment on seemingly unrelated events. All of these would come into play in litigation, if that is an option.
 

ellencee

Senior Member
chrisoco
I don't advise that you obtain your medical records. Have your regular physician request the records and then go over the sequence of events with her, or him.

It may be that you fractured your nose when the glass fell on it and it may be that in the presence of the fracture, the procedure to stop the bleeding extended the injury. The latter would not necessarily indicate malpractice.

You also state you had taken two Excedrin. Aspirin products and ibuprofen products thin the blood. Since you had a recent history of many OTC sinus/allergy products, your clotting time could have been increased thereby increasing the level of treatment needed to stop the bleeding.

You have a convoluted issue with no clear suggestion of malpractice. The injury to your facial bones from the falling glass is likely a contributing cause.

EC
 
C

chrisoco

Guest
RandallFabiano said:
First off, if you consented to the proceedure and it was performed flawless and you were informed of risks, success is not required. Meaning you have no case regardless of the outcome. You have to prove that the use of this device was outside the standard of care or absent consent. Even then it may be deemed erroneous. On the hospital paper you probably signed on entry it said if you have a claim, all claims shall be solved by binding arbitration. Most hospitals have it, and therefore, your ability to collect may be a bit hard.

The attending ENT at the second EMD (where my doctor sent me, not where the Rapid Rhino device was inserted) is who alerted us that the device likely was overinflated. I was explaining the pain I had experienced and he stated that, "ya know, 7-10 ml of balloon stuffed up your nose tends to do that." That's when my husband informed him that it was 20ml of air in the balloon. He jokingly asked if I had slugged the doc. It was after that that we looked into the manufacturer's notes regarding inflation. For my size and weight, 5-7ml was what should have been the standard.

The argument here is not that the device didn't come with assumed and informed risks. I was indeed told of tissue damage, the possibility that it wouldn't stop the bleeding and that I may have a reaction to the clotting agents in the device's wrapping. All of these assume that the doctor follows correct proceedures for insertion and inflation, which it seems he did not. Skull fractures and/or sinus fractures, are not considered normal risks of this proceedure and that is what I fear has happened.


OH! And as a note to RMT, the previous poster, in fact, I was aware that there were two types of these rhino devices. One has only one balloon and one has two balloons. Yes, the one with two balloons does have an inflation capacity of up to 20ml. The doctor had debated using that one on me but decided to try the less invasive one first. If it failed to stop the bleeding, he warned me that we would be forced to use the other device. After 17 hours, 7 hours short of the recommended time, the bleeding had stopped.
 
C

chrisoco

Guest
ellencee said:
chrisoco
I don't advise that you obtain your medical records. Have your regular physician request the records and then go over the sequence of events with her, or him.

Thank you.. as I was typing and thinking, that is what I thought would be best.

It may be that you fractured your nose when the glass fell on it and it may be that in the presence of the fracture, the procedure to stop the bleeding extended the injury. The latter would not necessarily indicate malpractice.

Okay.. I'm not communicating well... the glass never hit me in the nose. The glass was on the edge of a table. Long story, but I was in a fairly primative cabin at a camp, helping with records for the summer. The door slammed as someone went out and the glass threatened to topple onto papers we had been working hours on. I jumped up, papers in hand, trying to let go papers and catch the glass and then catch reading glasses that were falling off my nose. The combination resulted in my thumb bumping my nose, flinging my reading glasses across the room, dropping the papers and my co-worker catching the falling glass. It was the type of bump that made it not surprising that I would get a minor nose bleed, but as it escalated, it certainly seemed out of step with what happened. As I have had tests and consults since then, and no bruising, blood pressure, blood chem issues, we've let it go as a freak incident. Probably a cumulations of the cold, aspirin, decongestants and the bump.​

From there, when I traveled recently to TN, it was the first time since last year that I has traveled through decending and accending elevations. The pain was only on the one side, same side the device was placed on, and it was then that I started to realize that I had basically come to live with a certain amount of pain.. pain that had gotten better within the weeks/months after the proceedure, but pain that had not gone away. I started thinking and realizing that it was always that side that would have tinges of blood when I blew my nose and it was that side that would hurt when weather changed. It just all seemed to come together. And I wondered if I had more damage than I might have thought and if so, was it something that was within the expected parameters of risk. My answered seemed to be that it was due to what appeared to be a mistake. And while I don't want someone to "pay for what they did to me", I would appreciate it, if the device or the physician caused this, if the responsible party assisted in whatever care necessary to fix it. I just want my nose/sinus/cheek and eye not to hurt. I'm not looking to penalize anyone.
 

rmet4nzkx

Senior Member
chrisoco said:
Sounds like I need to start with getting my records and talking with my regular doctor about what exactly were her concerns and the details of the test results. Then on to a medmal attorney as EC directed. Do you think I should request my medical records from this EMD? Should I talk with the attorney first? :) Thinking out loud, sorry.

Thank you for a considerate reply,

Chris O'Connor
I asked my questions for a reason based on what you described happening. The presence of CSF is significant and the fact that they tested for it shows an appropriate level of care, including looking for bleeding disorder. Unfortunately, some clotting factors are accute reactants so you have a normal level upon test when trauma or bleeding are present and may test low when no abnormal signs of bleeding occur. You may have a bleeding disorder for many years without any symptoms.

There may be other things that happened that cannot be proved one way or the other, such as, did the glass hitting your nose, cause enough trauma to break the cribiform plate or was that caused by the inflation of the product? Your history of a potential head injury may be a factor even if you did not hit your head directly, your brain moves around during impact, some impacts to the back of the skull may produce fractures you describe. Fractures may spontaniously heal and years later reopen with minimal impact, so one of those blows to your head and or nose may have played into it.

If the CAT scan was too thick they wouldn't see the break in the cribiform plate, depending on how long has passed a MRI might show the break or if it healed, this is something your doctor may want to refer you for further diagnosis to get to the bottom of what happened and what can protect you in the future. It is also importnat to avoid exposure to perosons with things like mengititus.

ASA products like you took shortly before the initial bleed, may produce bleeding in sensitive individuals and or dehydration from the allergie medications.

According to the FDA there are 3 different makers of the product but the inflation level was WNL, however if your husband was given specific product information that would be why you didn't know.

Here is something on CSF leakage:
TITLE: DIAGNOSIS AND TREATMENT OF CSF LEAKS SOURCE: Dept. of ... must not crack the cribiform plate- most often ... Treatment of choice for CSF leaks associated with empty ... If leak diagnosed during the immediate postoperative http://www.utmb.edu/oto/Grand_Rounds_Earlier.dir/CSF_Leaks_1989.txt
 

ellencee

Senior Member
This is what I discovered through researching the sequence of events:
glancing blow to nose followed by epistaxis (nosebleed):
fracture of nasal bone and/or tear of the tissues, degree of injury varies; possible fracture of skull with CSF leak that may go undetected until bleeding is resolved.

epistaxis balloon tamponade: if inflated with air, leaks out quickly; saline or sterile water is recommended.

Nowhere did I find that over-inflation of the balloon would cause a skull fracture and, or cause leaking of CSF.

Since the MD used air instead of water or saline to inflate the balloon, no wonder he added more than the stated capacity of the balloon; the air was leaking out.

I do not believe it will be hard to prove that, more likely than not, the falling glass, which caused the series of events that caused the nose to be hit with more force than the poster was aware of at the time, is the proximate cause of the nosebleed, the need for balloon tamponade, and the leakage of CSF.

Don't let the statute of limitations run out before you consult with an attorney.

EC
 
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C

chrisoco

Guest
ellencee said:
epistaxis balloon tamponade: if inflated with air, leaks out quickly; saline or sterile water is recommended.
(...)
Since the MD used air instead of water or saline to inflate the balloon, no wonder he added more than the stated capacity of the balloon; the air was leaking out.
Actually, the device is saturated with saline or sterile water (saline in my case) before being placed in the nasal cavity and inflated. The water's adhesive properties is what keeps the air in the balloon. These devices are not filled with water ever as far as I know (Like I said earlier, my husband is a medic with 20 years field experience, including trauma background and teaching certs)

[/QUOTE]Don't let the statute of limitations run out before you consult with an attorney.[/QUOTE]

Okay, help? What are the rules here?
 

rmet4nzkx

Senior Member
When you see the attorney they will discuss with you what type of case you might have and statute of limitations. Go to the FDA link I gave you, that will give some divice information. It is important to find out what caused this so it doesn't happen in the future, so you still have to work with your doctor on the referrals. We can't give you a simple answer, but an attorney can take what you have and discuss your options.
 

rmet4nzkx

Senior Member
chrisoco said:
The attending ENT at the second EMD (where my doctor sent me, not where the Rapid Rhino device was inserted) is who alerted us that the device likely was overinflated. I was explaining the pain I had experienced and he stated that, "ya know, 7-10 ml of balloon stuffed up your nose tends to do that." That's when my husband informed him that it was 20ml of air in the balloon. He jokingly asked if I had slugged the doc. It was after that that we looked into the manufacturer's notes regarding inflation. For my size and weight, 5-7ml was what should have been the standard.

The argument here is not that the device didn't come with assumed and informed risks. I was indeed told of tissue damage, the possibility that it wouldn't stop the bleeding and that I may have a reaction to the clotting agents in the device's wrapping. All of these assume that the doctor follows correct proceedures for insertion and inflation, which it seems he did not. Skull fractures and/or sinus fractures, are not considered normal risks of this proceedure and that is what I fear has happened.


OH! And as a note to RMT, the previous poster, in fact, I was aware that there were two types of these rhino devices. One has only one balloon and one has two balloons. Yes, the one with two balloons does have an inflation capacity of up to 20ml. The doctor had debated using that one on me but decided to try the less invasive one first. If it failed to stop the bleeding, he warned me that we would be forced to use the other device. After 17 hours, 7 hours short of the recommended time, the bleeding had stopped.
As I said the pressures cited for your care were within normal limits and it appears it was correctly inserted. I believe you are confused between the dimentions (4.5 cm/25ml max ped's model),(adult models) 5.5 cm/30ml max, 7.5cm/40ml max, and the inflation levels, this is taken directly from the manufacturs instructions sheet provided for the doctors. It does not seem that there is neglience in it's use 20 ml is even less than the max on the peds model.

The thickness of the slice on the CAT is critical in determining if it was sufficiently thin to detect the location of the fracture. If this were the case, BTW this does happen, and the CSF leakage failed to heal in less than 5 days, most likely you required surgical repair, this is a result of your injury not the ER doctor and may be why you are still having problems. Surgical repair to the skull base is usually done by the ENT and Ellen refered you there, you will still need a referal to a hematologist prior to surgery to once again evaluate for bleeding disorders, if so infussion of a clotting agent can be tested prior to surgery and for future use as needed.

I have provided the main link and within that go to products click or the "support docs" buttons on the control bar and the "Quick reference" sheet will come up, you can print this out, I can't copy it here . Please take this information with you when you consult with an attorney.

Here is the manufactur's data:
RapidRhino.com - Applied Therapeutics, Inc. Simply dip the Rapid Rhino device in sterile water and it will start to gel as soon as it makes contact with the sterile water. ... What about the Rapid Rhino? ...
http://www.rapidrhino.com/index.cfm?fuseaction=products.faq

Do I need to fill the cuff with saline like I do with the Epistat balloon?

No, the Rapid Rhino nasal cuff requires only air, no fluids. Rapid Rhino provides gentle and even compression, unlike the high-pressure hydraulic forces created by fluid-filled silicone designed balloons. Silicone requires fluids due to its inability to maintain inflation without it. Hence, the Rapid Rhino nasal cuff design reduces the possibility of mucosal damage.

What is the inflation rate?

The critical parameter is pressure, not volume. The maximum volume of air will rarely be used. All Rapid Rhinos are capable of expanding to 25mm in diameter. The Rapid Rhino Anterior models (Ref. Nos. 550 and 551) use a maximum of 30ml of air from a syringe. The Rapid Rhino Anterior/Posterior (Ref. No. 750) uses approximately 40ml air, and the model used for smaller anatomies (Ref. No. 450) uses about 25ml air. While slowly inflating, gently compress the Pilot Cuff for direct tactile feeling of pressure inside the nasal cavity. Do not over-inflate.
 

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