BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U2 DRILL

    MDR report key: 2140383 · Received June 17, 2011

    Report

    Report Number
    1811755-2011-02181
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 20, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY THE MANUFACTURER AND THE DEVICE WOULD NOT FUNCTION. THE COMPLAINT WAS NOT DUPLICATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE WAS HEATING UP. THIS WAS DISCOVERED WHILE IT WAS BEING TESTED IN BIOMED. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U2 DRILL ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK