BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASEPTIC BATTER HOUSING

    MDR report key: 2431881 · Received January 6, 2012

    Report

    Report Number
    1811755-2012-00050
    Event Type
    Malfunction
    Date Received
    January 6, 2012
    Date of Event
    December 5, 2011
    Report Date
    December 20, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RECEIVED AT THE MANUFACTURER FOR EVALUATION BUT BASED ON THE QUALITY INVESTIGATION DETAILS THE REPORTED CONDITION OF THE HOUSING OPENING COULD NOT BE DUPLICATED. THE DEVICE WAS SCRAPPED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY HOUSING OPENED DURING A SURGICAL PROCEDURE. THERE IS NO REPORT THAT THE BATTERY FELL INTO THE SURGICAL SITE. THERE IS NO ALLEGATION OF ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASEPTIC BATTER HOUSING KIJ STRYKER INSTRUMENTS KALAMAZOO 04231

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK