BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERFECTEMP

    MDR report key: 402271 · Received June 28, 2002

    Report

    Report Number
    1030322-2002-00008
    Event Type
    Other
    Date Received
    June 28, 2002
    Report Date
    June 13, 2002
    Manufacturer
    AARON MEDICAL INDUSTRIES
    Product Code
    GEI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING DUAL SURGICAL PROCEDURE DOCTOR ATTEMPTED TO USE CAUTERY TO REMOVE A LESION ON PATIENT'S EYELID. THE PATIENT WAS RECEIVING SUPPLEMENTAL OXYGEN VIA MASK. WHEN THE DOCTOR ACTIVATED THE CAUTERY THE DRAPE AND 4/4 IGNITED SPONTANEOUSLY. THE ASSISTING NURSE REACTED IMMEDIATELY REMOVING THE BURNING DRAPE AND 4X4 AND STOMPING OUT THE FLAMES PREVENTING ANY INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFECTEMP HIGH TEMPERATURE FINE TIP CAUTERY GEI AARON MEDICAL INDUSTRIES 0231 0201-3

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention