BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T5 SUGICAL HELMET

    MDR report key: 2896713 · Received November 20, 2012

    Report

    Report Number
    1811755-2012-04146
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    FXZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING VISUAL INSPECTION AT THE USER FACILITY, IT WAS FOUND THAT THE CORD HAD A SLICE IN IT AND ONE INTERNAL WIRE WAS CUT, LEAVING BARE WIRES VISIBLE. NO PT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 T5 SUGICAL HELMET FXZ STRYKER INSTRUMENTS KALAMAZOO 11074

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK