FDA Adverse Event Injury Summary report: N

I DO NOT KNOW

MDR report key: 1816254 · Received August 22, 2010

Report

Report Number
MW5017225
Event Type
Injury
Date Received
August 22, 2010
Report Date
August 22, 2010
Product Code
FTL
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
TN, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

IN THE YEAR 2000, I HAD A TVT DONE FOR SUI, I DO NOT KNOW THE TYPE OF MESH USED. DURING THE SURGERY MY BLADDER WAS ACCIDENTALLY PERFORATED, BUT TO MY KNOWLEDGE HEALED WITH NO PROBLEM. MY DOCTOR DID INFORM ME THAT MY BLADDER HAD BEEN CUT ACCIDENTALLY. WITHIN ONE YEAR, I BEGAN HAVING FREQUENT UTI'S WITH NEGATIVE CULTURES. THE UTI'S WOULD COME AND GO AND I HONESTLY DID NOT RELATE THEM TO THE MESH. IN 2005, I BEGAN CONSTANTLY HAVING UTI'S WITH URGENCY, FREQUENCY - 15-20 TIMES A DAY- AND URETHRAL DISCOMFORT. THERE WAS SELDOM A MONTH I WASN'T ON ANTIBIOTICS - MACROBID OR CIPRO -, MY URINE WOULD MOST ALWAYS SHOW WVC'S AND RBC'S, WITH A NEGATIVE CULTURE. I HAVE CONTINUED TO SEE THE SAME UROLOGIST WHO PLACED THE MESH. OVER THE COURSE OF 5 YEARS, MY UROLOGIST PLACED ME ON DETROL - WHICH DID NOT HELP, I TRIED SEVERAL SURGICAL PROCEDURES UNDER GENERAL ANESTHESIA, BECAUSE I COULD NOT TOLERATE THE PAIN, 2 PROCEDURES FOR URETHRAL DILATION AND A BLADDER OVER HYDRO DISTENTION, AT WHICH TIME HE TOLD ME MY BLADDER LOOKED GOOD, NO ULCERS, NO SIGNS OF IC, THIS WAS 2008. MY SYMPTOMS HAVE PROGRESSIVELY GOTTEN WORSE, I CONTINUE TO HAVE SYMPTOMS OF UTI'S AND SEVERE PAIN IN MY URETHRA AND VAGINA. I HAVE BEEN ON MY OWN TRYING TO FIGURE OUT WHAT IS WRONG WITH ME. AS OF (B)(6) 2010, I HAVE MADE AN APPOINTMENT TO SEE A URO/GYN SPECIALIST, I MADE MY UROLOGIST AWARE AND REQUESTED MY RECORDS BE SENT. HE THEN SUGGESTED IT MAY BE IC. I DO NOT HAVE IC. I AM A BOARD CERTIFIED NEPHROLOGY NURSE AND CAN FIND NO REASON FOR MY SYMPTOMS. I CAN ONLY CONCLUDE THE PROBLEM IS THE MESH! I AM UNSURE HOW TO ANSWER THIS. I DO NOT KNOW THE MESH TYPE AT THIS TIME, BUT WILL FIND OUT. MESH WAS IMPLANTED IN 2000. I HAVE BEEN RECEIVING TREATED FOR OVER TEN YEARS WITH NO IMPROVEMENT. MY QUALITY OF LIFE IS GREATLY DIMINISHED AND I HAVE VOICED THIS TO THE UROLOGIST WHO PLACED THE MESH. I HAVE NO ANSWERS, NOR DO I KNOW WHERE TO GO TO SEEK HELP.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 I DO NOT KNOW TVT SLING 2000 FTL I DO NOT KNOW

Patients

Seq Age Sex Outcome Treatment
1 43 YR Hospitalization| O| R