BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYFORM SYNTHETIC MESH

    MDR report key: 3863867 · Received June 10, 2014

    Report

    Report Number
    3005099803-2014-02259
    Event Type
    Injury
    Date Received
    June 10, 2014
    Report Date
    June 2, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    OTP
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY THE PATIENT¿S ATTORNEY, A BOSTON SCIENTIFIC DEVICE WAS IMPLANTED.ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED PAIN DUE TO ERODED MESH, AS WELL AS, ADDITIONAL MEDICAL TREATMENT AND PROCEDURES. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341320 POLYFORM SYNTHETIC MESH MESH, SURGICAL, POLYMERIC OTP BOSTON SCIENTIFIC - MARLBOROUGH M0068402400 C000505

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention