BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSPEED UNI CONTROL UNIT W/COOL.UNIT

    MDR report key: 1070820 · Received July 3, 2008

    Report

    Report Number
    2916714-2008-00012
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Report Date
    June 13, 2008
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    HBC
    PMA / PMN Number
    K053526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT INCLUDES COMPONENT WHICH WAS BEING USED WITH THE CONTROL UNIT: MODEL#: GD455M, BRAND NAME: MICRO-LINE ANGULAR HDPC 1:2 F/2.35X70MM, COMMON DEVICE NAME: HWE, FACILITY REPORTED THE KLS MARTIN DRILL GUIDE WAS SUPPOSED TO BE RUN ON 5,000 RPM'S OR LESS AND WAS RUN ON 30,000 RPM'S. AESCULAP, INC ANTICIPATES THE DEVICE WILL BE RELEASED FROM THE USER FACILITY FOR EVAL; HOWEVER, IT IS UNKNOWN IF IT WILL BE RELEASED.

    Description of Event or Problem · 1

    WHILE USING THE MOTOR, HANDPIECE, AND A KLS MARTIN DRILL GUIDE ON AN OMF CASE. PATIENT WAS BURNED, ON THEIR CHEEK, WHILE IN OPERATION. INJURY WAS MINOR AND WAS TREATED WITH TOPICAL OINTMENT. SURGERY WAS NOT DELAYED. INJURY WAS SUPERFICIAL AND CONSISTED OF A SMALL BLISTER ON THE FACE NEAR INCISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSPEED UNI CONTROL UNIT W/COOL.UNIT HBC AESCULAP AG & CO. KG GD670

    Patients

    Seq Age Sex Outcome Treatment
    1