BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPOSE ULC

    MDR report key: 17388008 · Received July 25, 2023

    Report

    Report Number
    17388008
    Event Type
    Malfunction
    Date Received
    July 25, 2023
    Date of Event
    March 17, 2023
    Report Date
    March 28, 2023
    Manufacturer
    COVIDIEN
    Product Code
    GDT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    ATTEMPTED TO REPAIR HEAD LACERATION WITH STAPLES. STAPLE GUN BECAME LODGED TO PATIENT'S HEAD WHILE ATTEMPTING TO PLACE STAPLES. MULTIPLE DIFFERENT TOOLS HAD TO BE USED TO DETACH THE STAPLE GUN FROM THE PATIENT'S HEAD. AFTER GETTING ANOTHER STAPLE GUN, FNP WAS ABLE TO SUCCESSFULLY PLACE STAPLES. PT DID REQUIRE ADMINISTRATION OF LIDOCAINE ONCE STAPLE GUN BECAME LODGED, DUE TO PAIN. PT TOLERATED THE SECOND ATTEMPT AT STAPLE PLACEMENT WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426276 APPOSE ULC STAPLE, REMOVABLE (SKIN) GDT COVIDIEN 8886803712

    Patients

    Seq Age Sex Outcome Treatment
    1 2190 DA Male