BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEGIANCE

    MDR report key: 571935 · Received December 29, 2004

    Report

    Report Number
    1030322-2004-00012
    Event Type
    Malfunction
    Date Received
    December 29, 2004
    Date of Event
    November 30, 2004
    Report Date
    December 28, 2004
    Manufacturer
    AARON MEDICAL INDUSTRIES
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER FACILITY REPORTS THAT 3 UNUSED CAUTERIES WERE FOUND TO HAVE ACTIVATED WHILE IN THE SEALED POUCH. TWO CAUTERY POUCHES HAD A HOLE BURNED IN THE POUCH AND ONE POUCH WAS MELTED. NO FURTHER DAMAGE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEGIANCE HIGH TEMPERATURE FINE TIP DISPOSABLE CAUTERY GEI AARON MEDICAL INDUSTRIES AA01 1004-2

    Patients

    Seq Age Sex Outcome Treatment
    1 *