BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AARON MEDICAL

    MDR report key: 343358 · Received July 17, 2001

    Report

    Report Number
    1030322-2001-00004
    Event Type
    Malfunction
    Date Received
    July 17, 2001
    Date of Event
    March 6, 2001
    Report Date
    July 13, 2001
    Manufacturer
    AARON MEDICAL INDUSTRIES
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING USE OF CAUTERY, PHYSICIAN NOTED CAUTERY WAS EXTREMELY HOT AND RESULTED IN FLAMES TO TE STERILE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32338 AARON MEDICAL CAUTERY GEI AARON MEDICAL INDUSTRIES AA21 0100A

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention