BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100S STERILIZER

    MDR report key: 1082515 · Received July 24, 2008

    Report

    Report Number
    2084725-2008-00396
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 1, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K991999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (OTHER, SKIN CONTACT).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN EMPLOYEE WHO EXPERIENCED HYDROGEN PEROXIDE CONTACT ON THE LEFT SIDE OF HER PALM. THE EMPLOYEE WHO HANDLING A LOAD FROM A CANCELLED CYCLE WITHOUT WEARING GLOVES. THE EMPLOYEE REPORTED THAT THE CONTACT SITE TURNED WHITE AND FELT TINGLY. THE EMPLOYEE RINSED THE CONTACT AREA WITH WATER FOR 15 MINUTES. THE EMPLOYEE DID NOT SEEK MEDICAL ATTENTION OR REQUIRE TREATMENT. THE USER'S GUIDE WAS REVIEWED WITH THE CUSTOMER TO INSTRUCT HER TO WEAR APPROPRIATE PPE WHEN HANDLING ITEMS FROM A CANCELLED CYCLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERRAD 100S STERILIZER STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR