BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH SPEED SURGICAL HANDPIECE

    MDR report key: 506534 · Received January 5, 2004

    Report

    Report Number
    MW1030751
    Event Type
    Malfunction
    Date Received
    January 5, 2004
    Date of Event
    December 11, 2003
    Report Date
    January 5, 2004
    Manufacturer
    OSTEOMED CORP
    Product Code
    DZA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DRILL HANDPIECE HEATED UP AND CAME IN CONTACT WITH PT'S LIP. AFTER CASE, IT WAS NOTED THAT PT'S LIP WAS RED AND SWOLLEN ABOUT 1 CM IN SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIGH SPEED SURGICAL HANDPIECE STANDARD 1:1 HIGH SPEED STRAIGHT DRILL HANDPIECE DZA OSTEOMED CORP 405-0203 *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other