BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD NX STERILIZER

    MDR report key: 1111839 · Received August 13, 2008

    Report

    Report Number
    2084725-2008-00508
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 21, 2008
    Report Date
    July 21, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K042116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SKIN CONTACT - CAPITAL EQUIPMENT, UNIT EVALUATED AT THE FACILITY. THE FSE FOUND THE UNIT WORKING TO SPECIFICATIONS. ONE-SECOND DATA OBTAINED FROM THE UNIT SHOWED THAT THE CUSTOMER PROCESSED A LOAD THAT CONTAINED MOISTURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN EMPLOYEE WHO EXPERIENCED A BURNING SENSATION ON HER INDEX FINGER AFTER SHE REMOVED THE LOAD. THE EMPLOYEE REPORTED THAT THE CONTACT SITE TURNED WHITE. THE CUSTOMER REPORTED THAT THE EMPLOYEE DID NOT SEEK MEDICAL ATTENTION OR REQUIRE TREATMENT FOR THE CONTACT. THE ASP FIELD SERVICE ENGINEER (FSE) WENT TO THE FACILITY TO ASSESS THE UNIT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR