BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XOMED TRACE MICRO CRAFT EAR DRILL

    MDR report key: 17810 · Received July 29, 1994

    Report

    Report Number
    17810
    Event Type
    Malfunction
    Date Received
    July 29, 1994
    Date of Event
    January 7, 1994
    Report Date
    January 10, 1994
    Manufacturer
    XOMED TREACE, INC.
    Product Code
    EQJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MICRO CRAFT EAR DRILL STOPPED FUNCTIONING PRIOR TO THE END OF A CASE. MANUFACTURER REP WAS CONTACTED. HOSPITAL PERSONNEL WERE INFORMED THAT THE COMPANY IS AWARE OF THE PROBLEM BUT HAS NOT SENT NOTICE TO USERS REGARDING THE PROBLEM. ANOTHER PIECE OF EQUIPMENT WAS SUBSTITUTED AND THE CASE FINISHED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XOMED TRACE MICRO CRAFT EAR DRILL EAR DRILL EQJ XOMED TREACE, INC. MPS 2000

    Patients

    Seq Age Sex Outcome Treatment
    1 31 *