BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALLEYLAB ELECTROSURGICAL GENERATOR

    MDR report key: 320375 · Received March 9, 2001

    Report

    Report Number
    1717344-2001-00017
    Event Type
    Injury
    Date Received
    March 9, 2001
    Date of Event
    February 7, 2001
    Report Date
    February 7, 2001
    Manufacturer
    VALLEYLAB
    Product Code
    GEI
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER INDICATED A PT RECEIVED A BURN ON THE SIDE OF MOUTH DURING A TONSILLECTOMY, DESCRIBED AS A THIN LINE AT THE SIDE CREASE OF THE LIP. PLASTIC SURGERY MAY BE NECESSARY. THE BURN OCCURRED WHEN BIOPOLAR FORCEPS WERE RESTING AGAINST THE SIDE OF THE MOUTH AS THE SURGEON WAS COAGULATING THE TONSILE BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10329 VALLEYLAB ELECTROSURGICAL GENERATOR ELECTROSURGICAL GENERATOR GEI VALLEYLAB FORCE 2-20PC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR