BEUDAMED
    FDA Adverse Event Summary report: N

    MEDALIAN WASHER/STERILIZER

    MDR report key: 35363 · Received July 23, 1996

    Report

    Report Number
    35363
    Date Received
    July 23, 1996
    Report Date
    July 9, 1996
    Manufacturer
    AMERICAN STERILIZER CO
    Product Code
    FLE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AUTOCLAVE SET RAN ON WASHER CYCLE. ON EXHAUST-OPENED DOOR; BOILING WATER RAN OUT CAUSING BURN TO EMPLOYEE OPERATOR. EMPLOYEE SEEN AND TREATED IN EMERGENCY DEPARTMENT. DIAGNOSIS: 2ND DEGREE BSA PARTIAL THICKNESS BURNS BOTH FEET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDALIAN WASHER/STERILIZER STERILIZER FLE AMERICAN STERILIZER CO NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA