BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WIDE PORE POLYPROPELENE PRODUCT

    MDR report key: 2220381 · Received August 17, 2011

    Report

    Report Number
    MW5021807
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    February 2, 2011
    Report Date
    August 17, 2011
    Manufacturer
    AMS
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6), 2011, I HAD A MINI ARC SLING PROCEDURE USING TRANSVAGINAL MESH. WITHIN TWO DAYS, I CONTRACTED A URINARY TRACT INFECTION AND OVER SEVERAL DAYS, I DEVELOPED PAIN ACROSS THE BUTTOCK/LEG AREA AND THE PAIN STARTED DOWN THE BACK OF MY RIGHT LEG AS WELL. I DEVELOPED MUSCLE JERKING IN MY LEFT CALF AND SHOCKING LEG PAIN DOWN THE FRONT OF MY RIGHT LEG OVER THE NEXT FEW DAYS. OVER THE MONTHS, THE LEG PAIN WORSENED AS WELL AS I HAD CONSTANT RECURRING URINARY TRACT INFECTIONS. SEXUAL INTERCOURSE WITH MY HUSBAND WAS NOT POSSIBLE DUE TO THE PAIN. SADLY, THE DOCTOR WHO PERFORMED THE MINI ARC SLING PROCEDURE DID NOT DISCUSS WITH ME ANY COMPLICATIONS THAT COULD ARISE FROM THIS PROCEDURE. LIFE AS I KNEW IT WAS TAKEN FROM ME, AS WELL AS HAPPINESS AND JOY DUE TO THE COMPLICATIONS FROM THIS PROCEDURE. ON (B)(6), 2011, I WAS ABLE TO HAVE THE MESH REMOVED BY A UROLOGIST AT THE (B)(6). FORTUNATELY HE WAS ABLE TO REMOVE THE ENTIRE MESH AND I HAVE NOT HAD A URINARY TRACT INFECTION SINCE. THE LEG PAIN HAS IMPROVED GREATLY OVER THE PAST TWO MONTHS AS WELL AND MY LIFE IS RESUMING TO NORMAL. MY PRAYER IS THAT NO OTHER WOMEN WILL ENDURE THE HORRIBLE COMPLICATIONS THAT COME WITH TRANSVAGINAL MESH PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WIDE PORE POLYPROPELENE PRODUCT TRANSVAGINAL MESH FTL AMS

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Disability