BEUDAMED
    FDA Adverse Event Other Summary report: N

    MONOPOLAR CAUTERY FORCEPS

    MDR report key: 13007 · Received April 29, 1994

    Report

    Report Number
    MW1001783
    Event Type
    Other
    Date Received
    April 29, 1994
    Date of Event
    March 23, 1994
    Report Date
    March 28, 1994
    Manufacturer
    EDWARD WECK, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MONOPOLAR FORCEPS USED ON TONSILLECTOMY CAUSED A BURN ON TWO SMALL AREAS ON UPPER LIP OF PT. ON CLOSE EXAMINATION OF THE FORCEPS A FEW VERY MINUTE BUMPS WERE PRESENT ON THE SHAFT OF FORCEPS. THE BUMPY AREAS WERE ABRADED AS IF SOMETHING HAD RUBBED AGAINST THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOPOLAR CAUTERY FORCEPS MONOPOLAR CAUTERY FORCEPS GEI EDWARD WECK, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other