SURGICAL TAPE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-01-08 for SURGICAL TAPE manufactured by Johnson & Johnson.

Event Text Entries

[17461873] The caller reported that a johnson & johnson surgical tape was implanted in her by her doctor despite the mfrs warning about the side-effects of this product on pts with auto-immune disease. She had a history of about 10 auto-immune diseases before the doctor knowingly implanted the device in her. Now she suffers from numerous side effects including left sided paralysis, pain radiating all over the left part of her body and lost of life enjoyment. She also has painful sexual intercourse, occasionally poops on herself and has been to the emergency room more than thrice due to these side effects. During one of her visits to the er, after a ct-scan it was recommended that she undergoes surgery to extract the sling-tape because it had wrap around her lower abdomen and was the cause to all the side effects. Her doctor declined to carry out the procedure saying that she will die on the surgical table if this was done. Now she is only (b)(6) and has to live with all these horrible side effects. She finally found another doctor who has agreed to perform the surgery but neither her nor her family can afford (b)(6) for the procedure to be done and her insurance will not cover for it either. Now she is left with nothing but to live with side effects till her death. She wants the fda to investigate this issue and help protect innocent and helpless people like her self and the general public.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5028498
MDR Report Key2906608
Date Received2013-01-08
Date of Report2013-01-08
Date Added to Maude2013-01-11
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameSURGICAL TAPE
Generic NameSURGICAL MESH TAPE
Product CodeMCA
Date Received2013-01-08
Device Sequence No1
Device Event Key0
ManufacturerJOHNSON & JOHNSON


Patients

Patient NumberTreatmentOutcomeDate
10 2013-01-08

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.