BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYFORM¿ SYNTHETIC MESH

    MDR report key: 6156375 · Received December 8, 2016

    Report

    Report Number
    3005099803-2016-03711
    Event Type
    Injury
    Date Received
    December 8, 2016
    Report Date
    November 17, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    OTO
    PMA / PMN Number
    K051245
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 AN UNKNOWN INJURY. 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
    806531 POLYFORM¿ SYNTHETIC MESH MESH, SURGICAL, POLYMERIC OTO BOSTON SCIENTIFIC - MARLBOROUGH UNK164

    Patients

    Seq Age Sex Outcome Treatment
    1 Other