BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T4 POWER PACK

    MDR report key: 5022683 · Received August 21, 2015

    Report

    Report Number
    0001811755-2015-03071
    Event Type
    Malfunction
    Date Received
    August 21, 2015
    Date of Event
    July 31, 2015
    Report Date
    July 31, 2015
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    FXZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE USER FACILITY THE DEVICE WAS LEAKING ACID. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555387 T4 POWER PACK HELMET, SURGICAL FXZ STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1