BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDALLION PIWS

    MDR report key: 1488803 · Received October 1, 2009

    Report

    Report Number
    3005899764-2009-00008
    Event Type
    Injury
    Date Received
    October 1, 2009
    Date of Event
    September 14, 2009
    Report Date
    October 1, 2009
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    FLE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE UNIT AND DETERMINED THAT IT WAS OPERATING PROPERLY. PREVENTIVE MAINTENANCE WAS PERFORMED AND THE UNIT RETURNED TO SERVICE. AN IN-SERVICE TRAINING FOR THE FACILITY WILL BE SCHEDULED.

    Additional Manufacturer Narrative · 1

    A STERIS ACCOUNT MANAGER CONDUCTED AN IN-SERVICE ON NOVEMBER 9, 2009.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE EMPLOYEE IS FINE AND HAS NO SUSTAINING INJURIES.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT AN EMPLOYEE RECEIVED A STEAM BURN AS SHE REACHED INSIDE THE EQUIPMENT. THE EMPLOYEE UNLOCKED THE WASHER DOOR, PUT ON INSULATED GLOVES, THEN OPENED THE WASHER DOOR AND WAITED A MOMENT. WHEN SHE REACHED INSIDE, HER ARM WAS BURNED BY THE STEAM EXITING THE CHAMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDALLION PIWS MEDALLION STERILIZER FLE STERIS MEXICO, S. DE R.L. DE C.V. M1045003 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other