BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE

    MDR report key: 469041 · Received June 29, 2003

    Report

    Report Number
    MW1028839
    Event Type
    Injury
    Date Received
    June 29, 2003
    Date of Event
    March 21, 2001
    Report Date
    June 23, 2003
    Manufacturer
    ETHICON, INC. (A DIV. OF JOHNSON & JOHNSON )
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 9/30/03: QUESTION 1: THE ONLY INFO PROVIDED BY THE CUSTOMER IS THE PRODUCT CODE, 810041. NO LOT NUMBER WAS PORVIDED. THE PRODUCT WAS ALSO NOT AVAILABLE TO RETURN. DESPITE ATTEMPTS TO OBTAIN INFO REGARDING THE ACTUAL LOT NUMBER, NO ADD'L INFO COULD BE PROVIDED TO MFR BY THE CUSTOMER. THEREFORE, SINCE MFR WAS UNABLE TO OBTAIN THE DEVICE IN QUESTION AND NO LOT NUMBER COULD BE PROVIDED, NO EVALUATION OR LOT REVIEW COULD BE CONDUCTED. HOWEVER, TEMPORARY OR PERMANENT LOWER URINARY TRACT OBSTRUCTION IS A KNOWN POTENTIAL ADVERSE REACTION TO THIS PROCEDURE, WHEN OVER-CORRECTION I.E. TOO MUCH TENSION IS APPLIED TO THE TAPE. PLEASE SEE TVT INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    ON THE ABOVE DATE A CONSULTING GYNECOLOGIST INSERTED TRANS VAGINAL TAPE AFTER A VAGINAL HYSTORECTOMY AND A-P REPAIR WAS DONE. POST OPERATIVELY, PT WAS UNABLE TO VOID EXCEPT IN SCANT AMOUNTS AND PT WAS IN SEVERE PAIN. THREE MONTHS LATER THE TAPE WAS CUT AND PARTIALY REMOVED. PT WAS TOLD IT WAS TOO TIGHT TO ALLOW URINATION. PT WAS ALSO TOLD THAT THEIR CYSTOCALE WAS NOT REPAIRED CORRECTLY SO IT WAS REDONE (THIS SURGERY OCCURRED AT ANOTHER FACILITY). POST-OPERATIVELY PT WAS ABLE TO VOID BUT CONTINUED TO HAVE PAIN (PERINEAL AND RIGHT SIDE BUTTOCKS DOWN TO POPLITED SPACE). PT HAS HAD ELECTROMYOGRAPHY, SEVERAL PAIN MEDICATION AND EXLCUSIVE PHYSICAL THERAPY (WHICH INCLUDES E-STIM) BUT THEY HAVE NOT HAD ANY SIGNIFICANT IMPROVEMENT. A COUPLE OF MONTHS AGO WHILE REVIEWING SOME OF THEIR MEDICAL RECORDS, PT NOTICED THEY HAD A REACTION TO THE TAPE/SUTURES AND/OR PRODUCTS USED DURING THE SURGERY. PT WAS NEVER TOLD ABOUT THIS REACTION EVEN THOUGH THEY WENT BACK TO THIS FACILITY SEVERAL MORE TIMES WITH COMPLAINTS OF PAIN. RECENTLY PT HAVE READ ABOUT TAPE REACTION/REJECTION AND IS CONCERNED ABOUT NOT ONLY THE PAIN BUT ALSO THE POTENTIAL FOR LONG TERM COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE TRANSVAGINAL TAPE (POLYPROPYLENE MESH) FTL ETHICON, INC. (A DIV. OF JOHNSON & JOHNSON ) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| O| R| S INTERGEL.| SUTURES.