BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRODEBRIDER 1898200T IGS M4

    MDR report key: 3211186 · Received July 8, 2013

    Report

    Report Number
    1045254-2013-00443
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ERL
    PMA / PMN Number
    K041413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). DEVICE WAS NOT WORKING UPON RETURN FOR EVALUATION, THEREFORE COULD NOT CONFIRM THE REPORTED NOISE OR HEATING UP ISSUES.

    Description of Event or Problem · 1

    IT WAS REPORTED THE HANDPIECE WAS NOISY AND HEATING UP. THIS WAS DISCOVERED DURING TESTING , AND THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310762 MICRODEBRIDER 1898200T IGS M4 DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC XOMED, INC. 1898200T 48579700

    Patients

    Seq Age Sex Outcome Treatment
    1