BEUDAMED
    FDA Adverse Event Other Summary report: N

    CON-MED

    MDR report key: 269824 · Received March 17, 2000

    Report

    Report Number
    269824
    Event Type
    Other
    Date Received
    March 17, 2000
    Date of Event
    March 2, 2000
    Report Date
    March 17, 2000
    Manufacturer
    CON-MED ASPEN LABS
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING RIGHT LATERAL EPICONDYLAR SLIDE (ELBOW SURGERY). THE CAUTERY HOLDER WAS ON OPERATIVE FIELD BUT NOT USED. CAUTERY PENCIL WAS BUMPED BY STAFF AT APPROX 1300 CAUSING A 1CM 3RD DEGREE BURN TO ANTERIOR FOREARM-RIGHT. SILVADENE AND DRY STERILE DRESSING WERE APPLIED AFTER PROCEDURE COMPLETED. MD TO FOLLOW THIS AS AN OUTPATIENT. CAUTERY DID NOT MALFUNCTION. BOTH THE CAUTERY PENCIL AND THE PACKAGING WERE DISCARDED ARE UNABLE TO BE RETRIEVED. AN FDA (MEDWATCH) REPORT HAS BEEN COMPLETED AND SENT ON 03/17/2000.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CON-MED CAUTERY PENCIL GEI CON-MED ASPEN LABS * 99 KH A007

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other CON-MED CAUTERY MACHINE