Posted on 10/12/2002 4:17:28 PM PDT by Cobra64
Man almost bled to death as a result of a colonoscopy.
I've never heard of a contingency of more than 40%...If you pay a flat fee, what is the incentive for the lawyer to get all he can for you? If he's in on the cut he has a real incentive to get the client as much as possible. Make sense?
This is another good argument for lawsuits.
Katie Colon ...er Couric....(better late than never)
I can believe that! I had neck surgery almost 2 years ago and have more pain than I started with.
I knew there were risks and might not get any relief but it actually is getting worse.
I have been complaining to the surgeon and my GP and they send me for x-rays, physical therapy etc.
Two weeks ago I found out by accident that the plate they installed to hold the vertabra together is too long and the lower screws are drilled into the DISC instead of the bone. I can't get anyone to tell me if this is bad, not important or sure to cause me to start looking like Cristopher Reeve.
I finally got an appointment with the surgeon (a month from now). I expect another cycle of BS instead of just leveling with me. I feel like I have a hand grenade in my spine, but maybe not, who the hell knows!
Also go the the FDAs website and check the accident reports on the tool. Here is the link to search for accident reports on your tool. The manufacturer of mine had hidden the accidents involving the Innovatome Microkeratome from everyone including the people they sent out to TRAIN THE DOCTORS! There were 10+ other accidents (6 "accidents" prior to mine) that they hid from the FDA. They hid mine for 7 months until it became obvious the FDA was going to find out about it. I found out there are people willing to let people get blinded to protect their job. You always think people have a conscious like you, not so!
Here is what happened to me according to the medical manufacturer! I love the part where the patient is doing well!
|
|
510(k) | | | Registration | | | Listing | | | Adverse Events | | | PMA | | | Classification | | | CFR Title 21 | | | CLIA |
510(k) Exempt | | | Advisory Committees | | | Assembler | | | NHRIC | | | Guidance | | | Standards |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
DATE FDA RECEIVED | 02/23/2000 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
IS THIS AN ADVERSE EVENT REPORT? | YES | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
IS THIS A PRODUCT PROBLEM REPORT? | NO | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
DEVICE OPERATOR | HEALTH PROFESSIONAL | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
DEVICE MODEL NUMBER | 500-0012-2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
WAS DEVICE AVAILABLE FOR EVALUATION? | NO | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
IS THE REPORTER A HEALTH PROFESSIONAL? | YES | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
WAS THE REPORT SENT TO FDA? | YES | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
DATE REPORT TO FDA | 02/23/2000 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
DISTRIBUTOR FACILITY AWARE DATE | 05/18/1999 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
DEVICE AGE | 1 YR | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
EVENT LOCATION | OUTPATIENT TREATMENT FACILITY | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
DATE REPORT TO MANUFACTURER | 02/23/2000 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
DATE MANUFACTURER RECEIVED | 02/23/2000 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
WAS DEVICE EVALUATED BY MANUFACTURER? | NO | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
DATE DEVICE MANUFACTURED | 02/01/1999 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
IS THE DEVICE SINGLE USE? | NO ANSWER PROVIDED | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
TYPE OF DEVICE USAGE | REUSE | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
PATIENT OUTCOME | REQUIRED INTERVENTION |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
---|
REPORT DATE: 02/23/2000 MDR TEXT KEY: 908271 Patient Sequence Number: 1 |
SURGEON REPORTED TO CO'S MEDICAL DIRECTOR THAT THE APPLANUTOR HAD BEEN PUT ON THE SAPPHIRE UPSIDE DOWN. THE FLAP WAS SO THICK IT HAD TO BE HELD BACK. LASIK WAS PERFORMED WHILE HOLDING THE FLAP BACK. THERE WAS A PERFORATION WHICH CAUSED LEAKAGE. PATIENT HAD MINIMAL VISION AT POST-OP. PATIENT WAS DOING WELL AS OF 7/11/99. |
MANUFACTURER DEVICE EVALUATION SUMMARY |
REPORT DATE: 02/23/2000 MDR TEXT KEY: 908277 |
NA SEE ATTACHED |
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 02/23/2000 MDR TEXT KEY: 908278 |
SURGEON REPORTED TO CO'S MEDICAL DIRECTOR THAT THE APPLANATOR WAS PUT ON UPSIDE DOWN. THE FLAP WAS SO THICK IT HAD TO BE HELD BACK. LASIK WAS PERFORMED ON PT WHILE HOLDING THE FLAP BACK. THERE WAS A PERFORATION WHICH CAUSED LEAKAGE. PT SUTURED. AT POST-OP, THERE WAS SIGNIFICANT EDEMA AND THE PT HAD MINIMAL VISION AT THE TIME. PT WAS DOING WELL AT 7/11/99. PLEASE NOTE THAT THE FIRST REFERENCED EVENT HAS BEEN FILED BEYOND THE REQUESTED TIME FRAME. THE SECOND FILING IS WITHIN THE PRESCRIBED TIME FRAME. THE REASON FOR THIS LATE REPORT IS AS FOLLOWS: UPON CO'S INITIAL REVIEW OF THE FIRST EVENT, CO DETERMINED THAT, BECAUSE CO'S MICROKERATOME SYSTEM DID NOT "CAUSE" THE PERFORATION DESCRIBED IN THE REPORT, CO DID NOT FEEL IT NECESSARY TO FILE. THE EXCIMER LASER WAS THE DEVICE THAT CAUSED THE PERFORATION OF THE ANTERIOR CHAMBER DUE TO THE THINNESS OF THE REMAINING CORNEA. BOTH CASES CLEARLY DEMONSTRATE IMPROPER ASSEMBLY OF CO'S DEVICE BY THE TECHNICIAN LEADING TO DEEPER THAN NORMAL CUTS INTO THE CORNEA. IN ANY OTHER INCIDENT OF THIS NATURE, PROCEDURE WOULD BE TO REPLACE THE CORNEAL FLAP WITHOUT PROCEEDING WITH USE OF THE EXCIMER. THIS DID NOT OCCUR IN EITHER INCIDENT. CO HAS RECENTLY COMPLETED AN EXTENSIVE REVIEW OF FDA GUIDELINES. UPON REVIEW OF THE FIRST EVENT, CO DETERMINED A "CONTRIBUTORY FACTOR" IN SUCH AN INCIDENT MUST BE CONSIDERED DESPITE THE OPERATOR ERROR ASPECT, AND AS SUCH SHOULD BE REPORTED. NO H3 REFERENCE IS GIVEN AS DEVICE EVALUATION WAS NOT DEEMED NECESSARY. |
Database contains data received through June 27, 2002
CDRH Home | Search | A-Z Index | Feedback | Accessibility | Disclaimer
This kind of excessive bleeding is NOT normal after a colonscopy...but complications can happen. Sometimes these complications are from injury by the doctor, other times they are not anyone's fault. If you had polyps, they can bleed profusely. If you have diverticulitis or ulcerative colitis or any of a number of other conditions, your bowel can bleed after a procedure that would not similarly affect another person. Gastrointestinal net
I'd do some searching on the web and find support groups and message boards dealing with this subject and find a GOOD referral from someone who has been where you are.
I had the Fleet Phospho prep and it was deathly for me. I was so dehydrated I had the worst headache of my life and it took them 5 tries to get an IV going. I'm not looking forward to the next one.
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.