FDA Adverse Event Injury Summary report: N

UNK

MDR report key: 1212024 · Received October 24, 2008

Report

Report Number
MW5008764
Event Type
Injury
Date Received
October 24, 2008
Date of Event
September 5, 2007
Report Date
October 24, 2008
Manufacturer
UNK
Product Code
FTL
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CO, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

IN 2007- HAD MY UTERUS REMOVED AND A BLADDER PROLAPSE & RECTAL PROLAPSE REPAIR USING MESH. ON THE FOLLOWING MONTH, HAD SURGERY DUE TO MESH EROSION AND SEVERE INFECTION IN MY VAGINA. ON THREE MONTHS LATER, HAD SURGERY TO REPAIR & REMOVE MORE MESH AND REPAIR THE URETHRA AND REDUCE THE BLADDER SLING. THE MESH HAD MIGRATED TO ONE SIDE OF MY BLADDER AND THERE WAS MORE INFECTION WITH CONTINUAL BLADDER LEAKAGE OF URINE. BLADDER CONTINUED TO LEAK AND A CATHETER WAS PUT IN FOR SEVERAL WEEKS TO TRY AND HELP THE LEAKAGE AND BLADDER INFECTIONS. IN EARLY 2008, HAD SURGERY TO REMOVE MORE MESH AND REPAIR WORK WAS DONE TO THE URETHRA, DUE TO INFECTIONS AND LEAKAGE/INCONTINENCE. HAD A SUPRAPUBIC CATHETER PUT IN FOR 5 WEEKS. ON APPROX TWO MONTHS LATER, HAD DEVELOPED ABSCESSES ON BOTH SIDES OF MY BUTTOCKS DUE TO INFECTION FROM THE MESH FROM THE RECTOCELE PROCEDURE. HAD SURGERY TO REMOVE WHAT WE THOUGHT WAS ALL MESH. ON SIX MONTHS LATER- HAD ANOTHER SURGERY, DUE TO MY RECTAL MUSCLES NOT BEING ABLE TO CLOSE ALL THE WAY WHICH WAS FROM THE FIRST SURGERY PROCEDURE AND MORE MESH WAS FOUND AND REMOVED. THEY ALSO NEEDED TO REMOVE SCAR TISSUE FROM THE VAGINA. I HAVE STITCHES FROM MY VAGINA ALL THE WAY AROUND TO THE TOP OF MY RECTUM. I CONTINUE TO HAVE PROBLEMS WITH MY BLADDER LEAKING URINE IN SMALL AMOUNTS CONTINUALLY. DOSE OR AMOUNT: NA. DATES OF USE: 2007-2008. DIAGNOSIS OR REASON FOR USE: PROLAPSE BLADDER AND RECTUM.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 UNK TRANSVAGINAL SURGICAL MESH FTL UNK

Patients

Seq Age Sex Outcome Treatment
1 49 YR Hospitalization| R| S