BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100S STERILIZER

    MDR report key: 629388 · Received August 24, 2005

    Report

    Report Number
    2084725-2005-00353
    Event Type
    Malfunction
    Date Received
    August 24, 2005
    Date of Event
    February 7, 2005
    Report Date
    February 7, 2005
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A HEALTHCARE WORKER EXPERIENCED STINGING WITH WHITENING OF THE SKIN ON HER LEFT THUMB AS SHE REMOVED A BI POUCH FROM A LOAD AFTER A COMPLETED CYCLE. SHE RINSED THE CONTACT SITE UNDER COLD WATER AND HER SYMPTOMS RESOLVED WITHIN 2 HOURS. MEDICAL ATTENTION WAS NOT SOUGHT. THE VAPORIZER PLATE WAS IN PLACE AT THE TIME OF THE EVENT.

    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 50 YR