BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALLEYLAB

    MDR report key: 117774 · Received September 5, 1997

    Report

    Report Number
    MW1012039
    Event Type
    Injury
    Date Received
    September 5, 1997
    Date of Event
    August 26, 1997
    Report Date
    August 28, 1997
    Manufacturer
    VALLEYLAB, INC.
    Product Code
    FEH
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AUGUST 26, 1997 - 0815 - TONSILLECTOMY PERFORMED WITH DEVICE NOTED. CAUTERY UNIT SET AT 40 COAG. PROCEDURE TOLERATED WELL, RECOVERY UNEVENFUL. WHEN DISCHARGING PT, MOTHER NOTED SOMETHING WHITE AT THE RIGHT CORNER OF THE MOUTH AND RIGHT MID-SECTION OF TONGUE. DR. EXAMINED CHILD, FELT CHILD COULD STILL GO HOME. DR. SAW CHILD ON HIS OFFICE THE MORNING OF 8/27/97 DETERMINED THAT CHILD HAD SUSTAINED SERIOUS BURNS TO RIGHT ORAL CAVITY INVOLVING THE ROOF, TONGUE, CHEEK, AND CORNER OF LIPS. CHILD ADMITTED TO HOSP AFTERNOON OF 8/27/97 IN DEHYDRATION AND OBVIOUS PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALLEYLAB STERILE, DISPASABLE SUCTION COAGULATOR FEH VALLEYLAB, INC. * 17023 MFG APR 93

    Patients

    Seq Age Sex Outcome Treatment
    1 19 MO Hospitalization| O| R WITH COAGULATOR.| CAUTERY MACHINE AND GROUND PAD IN USE