BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERRAD 100NX STERILIZER

    MDR report key: 1150259 · Received September 3, 2008

    Report

    Report Number
    2084725-2008-00555
    Event Type
    Injury
    Date Received
    September 3, 2008
    Date of Event
    August 12, 2008
    Report Date
    August 12, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K071385
    Removal / Correction Number
    Z-1632-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CAPITAL EQUIPMENT, EVALUATED AT CUSTOMER SITE. THE FSE ARRIVED AND FOUND UNIT "READY TO USE." THE FSE CHECKED OIL FILTER ASSEMBLY FOR LEAKS, RAN EMPTY CHAMBER CYCLE AND MONITORED SYSTEM FOR ANY OIL MIST. NO OIL MIST FOUND. THE FSE PERFORMED REQUIRED TESTS. THE UNIT MEETS FACTORY SPECIFICATIONS. THIS ISSUE HAS BEEN ADDRESSED WITH A CUSTOMER LETTER RELATED TO CORRECTION & REMOVAL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN EMPLOYEE HAS BEEN "EXPERIENCING AN OILY TASTE IN THE BACK OF HIS THROAT A WEEK AND A HALF PRIOR TO SERVICE BEING COMPLETED ON THE 100NX FOR OIL MISTING." THE EMPLOYEE SOUGHT MEDICAL ATTENTION AND A CULTURE WAS TAKEN. MEDICATION WAS NOT PRESCRIBED. THE EMPLOYEE REPORTED THAT HE HAD A LOT OF PHLEGM MORE THAN USUAL. THE ASP FIELD SERVICE ENGINEER (FSE) WENT TO ASSESS THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERRAD 100NX STERILIZER STERILANT, CHEMICAL MLR ADVANCED STERILIZATION PRODUCTS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR STERRAD CASSETTE| EXP DATE: 1/24/2009