BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GIANTURCO-HELFRISH-EBERBASH

    MDR report key: 179637 · Received July 30, 1998

    Report

    Report Number
    179637
    Event Type
    Malfunction
    Date Received
    July 30, 1998
    Date of Event
    June 16, 1998
    Report Date
    July 8, 1998
    Manufacturer
    COOK SURGICAL
    Product Code
    EXN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE OUTER STAINLESS WIRE OF HERNIA MESH DETACHED FROM THE MESH AND MIGRATED TO PT'S LEFT THIGH. THE STAINLESS WIRE EVENTUALLY POKED THROUGH THE PT'S SKIN WHERE THE PT THEN PULLED THE REMAINING WIRE OUT THROUGH THE SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIANTURCO-HELFRISH-EBERBASH Implant HERNIA REPAIR SET EXN COOK SURGICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR