BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPS HANDPIECE CORD

    MDR report key: 2851287 · Received October 29, 2012

    Report

    Report Number
    1811755-2012-03953
    Event Type
    Malfunction
    Date Received
    October 29, 2012
    Date of Event
    October 19, 2012
    Report Date
    October 19, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    A TPS HANDPIECE CORD WAS SENT FOR SVC AND BIAS CURRENT WAS EXPERIENCED DURING PERFORMANCE TESTING. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TPS HANDPIECE CORD HRX STRYKER INSTRUMENTS KALAMAZOO 10169

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK