BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100S STERILIZER

    MDR report key: 707814 · Received August 19, 2005

    Report

    Report Number
    2084725-2005-00298
    Event Type
    Malfunction
    Date Received
    August 19, 2005
    Date of Event
    January 27, 2005
    Report Date
    February 1, 2005
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    HEALTHCARE WORKER EXPERIENCED BURNING AND WHITENING OF THE SKIN ON THE LEFT THUMB AFTER REMOVING A BI TEST KIT FROM A COMPLETED CYCLE. HE RAN WATER OVER THE CONTACT SITE AND THE SYMPTOMS RESOLVED IN 3-4 HOURS. MEDICAL ATTENTION WAS NOT SOUGHT. THE VAPORIZER PLATE WAS IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERRAD 100S STERILIZER STERILIZER MLR ADVANCED STERILIZATION PRODUCTS 10101 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR