BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 50 STERILIZATION SYSTEM

    MDR report key: 1032736 · Received April 22, 2008

    Report

    Report Number
    2084725-2008-00130
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    March 24, 2008
    Report Date
    March 24, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K981625
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED A CUSTOMER WITH HYDROGEN PEROXIDE CONTACT. THE HEALTHCARE WORKER HAD WHITE SKIN DISCOLORATION ON THEIR RIGHT MIDDLE FINGER AND THE LEFT WRIST. THE HEALTHCARE WORKER WAS SORTING ITEMS FROM A COMPLETED CYCLE OF RUBBER AND PLASTIC ITEMS WRAPPED IN PEEL POUCHES WHEN THE CONTACT OCCURRED. THE HEALTHCARE WORKER DID NOT SEEK MEDICAL ATTENTION OR REQUIRE TREATMENT FOR THE CONTACT. THE CONTACT AREAS RECOVERED WITHIN FIVE DAYS. THE AFFILIATE SENT SERVICE TO ASSESS THE UNIT AND REPORTED THAT THERE WERE NO PROBLEMS. THE VAPORIZER PLATE WAS IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERRAD 50 STERILIZATION SYSTEM STERILIZER MLR ADVANCED STERILIZATION PRODUCTS 10050 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK