FDA Adverse Event Injury Summary report: N

MESH

MDR report key: 2240778 · Received September 3, 2011

Report

Report Number
MW5022130
Event Type
Injury
Date Received
September 3, 2011
Date of Event
June 30, 2011
Report Date
September 3, 2011
Product Code
FTL
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CT, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

PAIN ON RIGHT SIDE RUNS FROM THE FRONT TO BACK AND LOWER LEG. I HAD A MESH IMPLANT DONE TO CONTROL MY URINE. I HAVE BEEN SEEN BY MY REGULAR DOCTOR, HAD A CT SCAN DONE TO RULE OUT APPENDIX. SHE SAID I SHOULD SEE A "GASTROLOGYS." I AM CONCERNED THE MESH MAY HAVE WRAP AROUND ANOTHER ORGAN. I STILL HAVE ACTIVE BLADDER, THE URINE IS FREQUENTLY. I HAVE SOME BLOOD DISCHARGED BUT THE GYN IS NOT CONCERNED. I HAVE BEEN IN PAIN FOR ABOUT 6 MONTHS. UNFORTUNATELY AT THIS MOMENT I AM UNEMPLOYED WITHOUT INSURANCE. MY DOCTORS ARE VERY EXPENSIVE. A 2008 BLADDER MESH. LAST TIME I SAW PHYSICIAN, I WAS TOLD ONLY GO SEE HIM IF I HAD DISCOMFORT. I HAD A CT SCAN, ULTRASOUND AND XRAYS DONE IN (B)(6) 2011 FOR THE PAIN ON THE LOWER RIGHT SIDE. TEST DONE AT RADIOLOGY, DR. (B)(6) OFFICE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MESH BLADDER MESH FTL

Patients

Seq Age Sex Outcome Treatment
1 47 YR Disability