BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON/MODIFIED TRINKLE ATTACH

    MDR report key: 2082061 · Received April 26, 2011

    Report

    Report Number
    1811755-2011-01401
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR EVAL. SAMPLES OF THE LIQUID WERE TAKEN FOR ANALYSIS. A F/U REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS LEAKING AN OIL-LIKE RESIDUE IN THE STERILIZATION CASE. THERE WAS NO PT INVOLVEMENT AND NO ALLEGATION OF ADVERSE CONSEQUENCE ASSOCIATED WITH THIS EVENT. THE ACCOUNT HAD A BACK UP ON HAND TO COMPLETE THE PROCEDURE WITH NO DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON/MODIFIED TRINKLE ATTACH KIJ STRYKER INSTRUMENTS KALAMAZOO 10168

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK