BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100S STERILIZER

    MDR report key: 1111856 · Received August 13, 2008

    Report

    Report Number
    2084725-2008-00516
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 24, 2008
    Report Date
    July 24, 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

    SKIN CONTACT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN EMPLOYEE EXPERIENCED HYDROGEN PEROXIDE CONTACT. THE EMPLOYEE REPORTED THAT THE AREA OF CONTACT APPEARED WHITE AND OCCURRED ON THE PALM OF HIS HAND AND FINGERTIPS. EMPLOYEE WASHED HIS HAND IN WATER AND THE NEXT DAY, IT WAS "GONE ALMOST 90%". THE EMPLOYEE DID NOT SEEK MEDICAL ATTENTION OR REQUIRE TREATMENT FOR THE CONTACT. THE CUSTOMER CONFIRMED THAT THE VAPORIZER PLATE WAS IN PLACE AND THE LOAD WAS FROM AN "ABORTED" CYCLE. USER WAS NOT WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE).

    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 UNK