BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOHNSON AND JOHNSON

    MDR report key: 3140855 · Received May 28, 2013

    Report

    Report Number
    MW5030352
    Event Type
    Injury
    Date Received
    May 28, 2013
    Date of Event
    March 14, 2011
    Report Date
    May 20, 2013
    Manufacturer
    ETHICON
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    INGUINAL HERNIA DUE TO DA VINCI ROBOTIC SURGERY FOR PROSTATE CANCER, IMPLANTED WITH ETHICON PROLENE HERNIA MESH. POST SURGERY GROIN PAIN DIAGNOSED, (B)(6), AS NERVE DAMAGE. INCLUDES BOWEL PROBLEMS, SWOLLEN TESTICLE, LEG AND GROIN PAIN, KIDNEY PAIN, FLATULENCE, INCREASED STRESS URINARY INCONTINENCE, INCREASED BLOOD PRESSURE. (B)(6) HOSPITAL HAS TREATED WITH NOVOCAIN AND STEROID INJECTIONS, GABAPENTIN, NORTRIPTYLINE, DESIPRAMINE, HYDROCODONE, CODEINE, MORPHINE, NONE OF WHICH WORKED. COMPLICATIONS ARE ON THE INCREASE WITH NO CLEAR DIAGNOSIS FOR TREATMENT. (B)(6) HAS TRIED NERVE DAMAGE TO HERNIA REPAIR AND THE HERNIA REPAIR TO THE DA VINCI CANCER SURGERY. (SEE: MEDWATCH FILED THIS DATE, SAME REPORTER, DA VINCI ROBOTIC SURGICAL SYSTEM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233309 JOHNSON AND JOHNSON PROLENE HERNIA MESH FTL ETHICON PM II CGR 682

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other