BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T5 HELMET W/T4 FO LIGHT

    MDR report key: 2621203 · Received June 11, 2012

    Report

    Report Number
    1811755-2012-02189
    Event Type
    Malfunction
    Date Received
    June 11, 2012
    Date of Event
    May 15, 2012
    Report Date
    May 15, 2012
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    FXZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED FOR EVALUATION; ADDITIONAL INFO WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A BURN ON THE FIBER OPTIC CABLE DURING TESTING. THERE WAS NO PT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 T5 HELMET W/T4 FO LIGHT FXZ STRYKER INSTRUMENTS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK