BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLSEN

    MDR report key: 80111 · Received March 24, 1997

    Report

    Report Number
    2916288-1997-00001
    Event Type
    Injury
    Date Received
    March 24, 1997
    Report Date
    March 24, 1997
    Manufacturer
    OLSEN ELECTROSURGICAL INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A TONSILLECTOMY, SPARKING OCCURRED WHICH CAUSED A MINOR PT BURN ON THE MOUTH. A FOOT-ACTIVATED SWITCH PEN WAS USED WITH ANOTHER CO'S GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLSEN DISPOSABLE FOOT ACTIVATED SWITCH PEN GEI OLSEN ELECTROSURGICAL INC. 950 015367

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other