BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMMER IV HANDPIECE

    MDR report key: 2050007 · Received March 14, 2011

    Report

    Report Number
    1811755-2011-00812
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 15, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K011381
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY THE MFR AND AN INVESTIGATION IS ANTICIPATED. A F/U REPORT WILL BE SUBMITTED IF THE INVESTIGATION RESULTS REQUIRE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING EQUIPMENT TESTING, CONDUCTED AT THE USER FACILITY, THE MICRODEBRIDER HEATED UP. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, SO THERE WAS NO PT INVOLVEMENT. NO USER INJURY WAS REPORTED, AND NO ADVERSE CONSEQUENCES WERE ALLEGED WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMMER IV HANDPIECE DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC), INCL ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK