BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILIZATION CASE

    MDR report key: 2150312 · Received June 7, 2011

    Report

    Report Number
    1811755-2011-02033
    Event Type
    Malfunction
    Date Received
    June 7, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 10, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION AND THE SERIAL NUMBER WAS NOT PROVIDED. THE DEVICE HISTORY RECORD CANNOT BE REVIEWED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COATING ON THE STERILIZATION TRAYS IS WEARING OFF. THERE WAS NO PATIENT INVOLVEMENT AND NO ALLEGATION OF ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERILIZATION CASE KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK