BEUDAMED
    FDA Adverse Event Other Summary report: N

    OSTEOMED

    MDR report key: 330487 · Received May 8, 2001

    Report

    Report Number
    MW1021813
    Event Type
    Other
    Date Received
    May 8, 2001
    Date of Event
    April 24, 2001
    Report Date
    May 8, 2001
    Manufacturer
    OSTEOMED CORP
    Product Code
    HTW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DEVICE HAS A STRAIGHT DRILL WITH A BUR GUARD ATTACHMENT WHICH HAS A BALL BEARING IN IT. THE BALL BEARING OVERHEATED AS DR WAS DRILLING INTO THE BONE. BUR GUARD WAS AGAINST PT'S LIP AND PT SUSTAINED A BURN WHICH APPEARED TO BE THIRD DEGREE. PRIMARY ESCHAR REMOVAL DONE WITH A PRIMARY CLOSURE. MFR NOTIFIED. SALES REP SAW DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21036 OSTEOMED SURGICAL HANDPIECE, DRILL HTW OSTEOMED CORP * *
    21080 OSTEOMED SURGICAL HANDPIECE, BUR GUARD HTW OSTEOMED CORP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other