BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N/A

    MDR report key: 675 · Received June 9, 1992

    Report

    Report Number
    675
    Event Type
    Injury
    Date Received
    June 9, 1992
    Date of Event
    May 13, 1992
    Report Date
    May 27, 1992
    Manufacturer
    VALLEY LAB
    Product Code
    EKZ
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    DURING THE SURGICAL PROCEDURE OF A T & A THE GUAZE PACKING IN THE CHILD'S MOUTH CAUGHT ON FIRE FROM THE BOVIE. FLAMES CAUSED MOUTH RETRACTOR TO BURN AND CAUSED BURNS ON THE INSIDE OF THE PATIENT'S MOUTH AS WELL AS PORTIONS ON THE OUTSIDE. FLAMES WERE EXTINGUISHED WITH LARGE AMOUNTS OF WATER. CHILD WAS TREATED WITH ANTIBIOTIC CREAM. CHILD WAS KEPT OVER NIGHTDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: NONE OR UNKNOWN, MATED WITH INCOMPATIBLE EQUIPMENT, OTHER, OTHER. CONCLUSION: OTHER. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A ELECTRO SURGICLAL UNIT ESU EKZ VALLEY LAB FORCE TWO S9921/B0798

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention