BEUDAMED
    FDA Adverse Event Injury Summary report: N

    16 INCH PIWS

    MDR report key: 75607 · Received March 6, 1997

    Report

    Report Number
    2515984-1997-00002
    Event Type
    Injury
    Date Received
    March 6, 1997
    Date of Event
    January 21, 1997
    Report Date
    February 27, 1997
    Manufacturer
    STERIS (FORMERLY AMSCO)
    Product Code
    FLE
    Removal / Correction Number
    MA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OPERATOR OPENED THE DOOR OF THE WASHER-STERILIZER AND WATER POURED OUT BURNING THE OPERATOR'S LEGS AND FEET. OPERATOR'S BURNS WERE 3RD DEGREE. TEST CYCLE CONDUCTED AFTER THE EVENT RAN CORRECTLY. CAUSE OF WATER IS UNK, BUT INCORRECT MANUAL OPERATION OF UNIT IS THE MOST PROBABLE CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 16 INCH PIWS WASHER-STERILIZER FLE STERIS (FORMERLY AMSCO) AN6400000000000000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention