BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVAGINAL MESH

    MDR report key: 4231675 · Received November 2, 2014

    Report

    Report Number
    MW5038957
    Event Type
    Injury
    Date Received
    November 2, 2014
    Report Date
    November 2, 2014
    Manufacturer
    GYNECARE
    Product Code
    OTO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MAJOR INCONTINENCE WEIGHT LOSS, WEIGHT GAIN, PAIN, UTIS, VOMITING NAUSEA, DIARRHEA, KIDNEY PAIN, FLANK PAIN, DEPRESSION, ANXIETY, HEADACHES, SEVERE FATIGUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700768 TRANSVAGINAL MESH TRANSVAGINAL MESH OTO GYNECARE 81004B

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization| L| R| S