BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPOSE & UNITY

    MDR report key: 343974 · Received July 24, 2001

    Report

    Report Number
    MW1022478
    Event Type
    Injury
    Date Received
    July 24, 2001
    Date of Event
    July 12, 2001
    Report Date
    July 13, 2001
    Manufacturer
    DAVIS & GECK/AMERICAN CYANAMID CO
    Product Code
    GDT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ER PHYSICIAN ATTEMPTED TO STAPLE SKIN. FIRST STAPLER JAMMED. WOULD NOT RELEASE STAPLES. SECOND STAPLER PARTIALLY CLOSED THROUGH PT'S SKIN. DID NOT RELEASE FROM STAPLER - DEVICE WAS "BROKEN" WITH HAND TOOLS TO RELEASE STAPLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33276 APPOSE & UNITY DISPOS. SKIN STAPLER GDT DAVIS & GECK/AMERICAN CYANAMID CO 8025-12 (35W) 1018055

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention