BEUDAMED
    FDA Adverse Event Other Summary report: N

    HIGH TEMP

    MDR report key: 695451 · Received March 24, 2006

    Report

    Report Number
    695451
    Event Type
    Other
    Date Received
    March 24, 2006
    Date of Event
    March 23, 2006
    Report Date
    March 24, 2006
    Manufacturer
    AARON MEDICAL INDUSTRIES
    Product Code
    GEI
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE DISPOSABLE PORTION OF THE CAUTERY UNIT CREATED A FIRE IN THE SHARPS CONTAINER WHICH HAD TO BE PUT OUT. THE USERS HAVE BEEN TRAINED TO DISPOSE OF THE DEVICE PROPERLY BUT IT DOES SEEM THAT THIS MIGHT BE A FLAW IN THE DESIGN OF UNIT WHICH WOULD ALLOW IT TO HAPPEN IN THE FIRST PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIGH TEMP CAUTERY, BATTERY OPERATED GEI AARON MEDICAL INDUSTRIES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *