BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERRAD 100S STERILIZER

    MDR report key: 1083507 · Received July 29, 2008

    Report

    Report Number
    2084725-2008-00402
    Event Type
    Injury
    Date Received
    July 29, 2008
    Date of Event
    July 2, 2008
    Report Date
    July 2, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K991999
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CAPITAL EQUIPMENT, UNIT EVALUATED AT THE FACILITY. THE FSE RAN A UNIT PRODUCT CERTIFICATION AND AN EMPTY TEST CYCLE. THE UNIT MET SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HYDROGEN PEROXIDE CONTACT AFTER REMOVING A LOAD FROM A COMPLETED CYCLE. THE EMPLOYEE REPORTED SEEING OIL LIKE SUBSTANCE ON THE OUTSIDE OF THE WRAP. THE EMPLOYEE WAS SEEN IN THE ER AND WAS TREATED WITH SILVADENE CREAM. THE EMPLOYEE RECOVERED WITHOUT INCIDENT. THE ASP FIELD SVC ENGINEER (FSE) WENT TO THE FACILITY TO ASSESS THE UNIT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK