FDA Adverse Event Other Summary report: N

NOT KNOWN

MDR report key: 1220920 · Received November 4, 2008

Report

Report Number
MW5008881
Event Type
Other
Date Received
November 4, 2008
Date of Event
July 8, 2008
Report Date
November 4, 2008
Product Code
FTL
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
LA, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

I HAD SURG IN 2008, HYSTERECTOMY WITH CYSTOCELE REPAIR TVT INSERTION. SIX WEEKS POST-OP, I WAS FINE FOR MY CHECK UP. DOCTOR DID NOT DETECT ANY PROBLEMS & NEITHER DID I. TWO WEEKS LATER, I STARTED FEELING SOMETHING INSIDE THAT JUST DID NOT FEEL RIGHT, LIKE SOMETHING WAS STICKING ME. ALSO RESUMED SEXUAL RELATIONS & MY SPOUSE NOTICED SOMETHING WAS SCRATCHING HIM. MEANWHILE I WAS ALSO HAVING CONTINUOUS BLEEDING AFTER THE SIX WEEKS AND VAGINAL ODOR. ALSO DEVELOPED A SEVERE YEAST INFECTION THAT WOULD NOT GO AWAY WITH OVER THE COUNTER MEDICATION. RETURNED TO THE MD AND HE STATED THAT I HAVE EXPOSURE OF TAPE FROM THE BLADDER SUSPENSION. HE CUT SOME OF THE TAPE THAT HE COULD. CHECKED MY URINE & HAD ELEVATED WBC & WAS DX WITH YEAST INFECTON. WAS TX WITH DIFLUCAN AND ABX. FOR UTI. WEEK LATER STILL HAVING URINARY URGENCY AND YEAST INFECTION. BACK. WAS TX FOR 3 EPISODES OF YEAST INFECTION. WOULD TRY TO HAVE SEX BUT WOULD HURT TOO BAD. MEANWHILE ALSO TX WITH PREMARIN TO SEE IF TISSUE GROWTH WOULD OCCUR. EIGHT WEEKS LATER WAS RETURNED TO MD AND SOME TISSUE GROWTH NOTED, BUT STILL SHALLOW AND MD STATES CONTINUED TO USE PREMARIN CREAM, CAN HAVE INTERCOURSE AS DESIRED, THAT I MAY HAVE A RESISTANT TYPE YEAST INFECTION OR CANDIDA. GIVEN BORIC ACID VAGINAL SUPPOSITORIES. STILL HAVE PAIN AND CAN FEEL EXPOSED TAPE. I AM GOING TO SEEK SECOND OPINION. I'M CONCERNED DUE TO THE FDA REPORT THAT I HAVE SEEN THAT IF DO NOTHING THAT THERE COULD BE EVEN WORSE COMPLICATIONS THAT COULD APPEAR. DIAGNOSIS OR REASON FOR USE: URINARY INCONTINENCE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 NOT KNOWN TVT FTL

Patients

Seq Age Sex Outcome Treatment
1 43 YR Other