BEUDAMED
    FDA Adverse Event Other Summary report: N

    HALL SURGICAL BURR GUARD

    MDR report key: 830004 · Received March 16, 2007

    Report

    Report Number
    1017294-2007-00171
    Event Type
    Other
    Date Received
    March 16, 2007
    Date of Event
    February 19, 2007
    Report Date
    February 22, 2007
    Manufacturer
    CONMED LINVATEC
    Product Code
    EQJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: THREE BUR GUARDS WERE RECEIVED FOR EVALUATION AS THE CUSTOMER WAS UNAWARE OF WHICH BUR GUARD WAS USED AT THE TIME OF BURN INJURY. THE REPORTED PROBLEM OF OVERHEATING WAS UNCONFIRMED, AS ALL THREE DEVICES WERE FOUND TO HAVE DAMAGED BEARINGS RENDERING THEM INOPERABLE FOR TESTING. IT WAS ALSO NOTED THAT PREVENTATIVE MAINTENANCE WAS OVERDUE ON ALL THREE UNITS. THE CUSTOMER WILL BE CONTACTED WITH INFO REGARDING THIS PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF A BUR GUARD IN AN ORAL PROCEDURE, THE DEVICE OVERHEATED RESULTING IN A BURN TO THE RIGHT LOWER MUCOSA OF THE PT'S MOUTH. IT WAS REPORTED BY THE USER, THAT THE HANDPIECE DID NOT OVERHEAT. THE BURN SITE WAS DEBRIDED, THE PT RECEIVED ANTIBIOTICS AND WAS DISCHARGED HOME. IT WAS REPORTED THAT DURING A FOLLOW UP VISIT, THE BURN SITE WAS NOTED AS HEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALL SURGICAL BURR GUARD BUR GUARD EQJ CONMED LINVATEC NA FEB05S

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other UNIVERSAL HOSE, CAT#00505201000| LOT# UNK| SURGAIRTOME TWO DRILL,| CAT # 00505800100, SERIAL# UNK