BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE FIT

    MDR report key: 3072830 · Received April 17, 2013

    Report

    Report Number
    MW5029860
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    March 10, 2010
    Report Date
    April 17, 2013
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD BLADDER REPAIR SURGERY WITH IMPLANT OF ADVANTAGE FIT SLING. M0068502111. I HAVE HAD RIGHT-SIDED GROIN PAIN, FATIGUE, MUSCLE CRAMPING FOLLOWING SURGERY. I NOW USE CRUTCHES AND A MEDICAL CART BECAUSE I CANNOT PUT ANY WEIGHT ON MY RIGHT LEG WITHOUT EXCRUCIATING PAIN. I HAVE CONSTANT PAIN AND ON PAIN MEDICATION DAILY WHICH DOESN'T ALLEVIATE THE PAIN. I ALSO HAVE DAMAGE TO MY FEMORAL NERVE AND RIGHT QUADRICEP ATROPHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166667 ADVANTAGE FIT BLADDER SLING FTL BOSTON SCIENTIFIC M0068502111

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R| S