BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARCH

    MDR report key: 1803011 · Received August 13, 2010

    Report

    Report Number
    MW5017091
    Event Type
    Injury
    Date Received
    August 13, 2010
    Date of Event
    September 14, 2009
    Report Date
    August 13, 2010
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT IS EXPERIENCING SMELLY URINE, FATIGUE, LETHARGY, WEAKNESS, TROUBLE SLEEPING, WALKING DIFFICULTIES AND RECURRENT, UNRESOLVED E COLI INFECTIONS. PT HAS TAKEN MANY ABT REGIMENS IN 6 MOS AND IS CURRENTLY ON LOW DOSE DAILY ABT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONARCH BLADDER/URINARY SLING FTL 39-85-51

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other