BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLITE POLYPROPYLENE MESH

    MDR report key: 3020732 · Received March 18, 2013

    Report

    Report Number
    MW5029445
    Event Type
    Injury
    Date Received
    March 18, 2013
    Date of Event
    August 20, 2001
    Report Date
    March 18, 2013
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HERNIA MESH FAILURE AND COMPLICATIONS. DIAGNOSIS OR REASON FOR USE: HERNIA REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111949 PROLITE POLYPROPYLENE MESH MESH FTL ATRIUM MEDICAL CORPORATION 11622299

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other| R