BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALL AMERICAN ELECTRIC PRESSURE STEAM STERILIZER

    MDR report key: 547698 · Received July 2, 2004

    Report

    Report Number
    MW1032509
    Event Type
    Injury
    Date Received
    July 2, 2004
    Date of Event
    June 24, 2004
    Report Date
    July 2, 2004
    Manufacturer
    WISCONSIN ALUMINUM FOUNDRY CO., INC.
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RPTR WAS AUTO CLAVING INSTRUMENTS. THE AUTO CLAVE EXPLODED. LID POPPED OFF AND WENT THROUGH THE CEILING. NO ONE WAS IN THE ROOM; NO INJURY OCCURRED. AUTOCLAVE LID IS 13 INCHES IN DIAMETER AND IS MADE OF HEAVY METAL. SIX BOLTS ARE SCREWED ONTO LID TO HOLD IN PLACE. EMPLOYEE OPERATING DEVICE VERY EXPERIENCED WITH IT. RPTR PLANS ON TURNING DEVICE OVER TO THE MFR IF FDA IS NOT INTERESTED IN EXAMINING IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALL AMERICAN ELECTRIC PRESSURE STEAM STERILIZER AUTO CLAVE FLE WISCONSIN ALUMINUM FOUNDRY CO., INC. 25X *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Life Threatening