BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARC SLING

    MDR report key: 3870247 · Received June 6, 2014

    Report

    Report Number
    MW5036547
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    October 10, 2003
    Report Date
    June 5, 2014
    Manufacturer
    AMS
    Product Code
    OTN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MONARC SLING WAS PLACED AROUND MY URETHRA AND IS NOW CAUSING MAJOR PROBLEMS: PROTRUSION, PELVIC PAIN, KIDNEY INFECTIONS, BLADDER INFECTIONS, PAINFUL INTIMACY, KIDNEY STONES, UTI'S, BLEEDING, INNER THIGH AND PUBIC SPASMS, YEAST INFECTION, VOMITING, DIARRHEA, LIGHT HEADEDNESS, FATIGUE, LEG PAIN (UNABLE TO WALK AT TIMES) AND STOMACH PAIN. RELEVANT TESTS: KIDNEY STONES, BLADDER TEST, KIDNEY TEST, UTI AND URINARY TEST, AND BLOOD TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331517 MONARC SLING MONARC SLING OTN AMS

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R