BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVISOFT

    MDR report key: 2932533 · Received January 25, 2013

    Report

    Report Number
    MW5028736
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    October 26, 2010
    Report Date
    January 14, 2013
    Product Code
    FTM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Description of Event or Problem · 1

    STATUS POST. PELVISOFT GRAFT PLACEMENT FOR ANTERIOR COLPORRHAPHY AND TOT, HAS CHRONIC VAGINAL DISCHARGE AND PAIN. EROSION OF PERMANENT SUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36153 PELVISOFT NONE FTM

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization