BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICAL HANDPIECE 3555

    MDR report key: 1163543 · Received September 17, 2008

    Report

    Report Number
    1419798-2008-00016
    Event Type
    Injury
    Date Received
    September 17, 2008
    Date of Event
    August 15, 2008
    Report Date
    August 20, 2008
    Manufacturer
    KALTENBACK & VOIGT GMBH
    Product Code
    EFA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE HANDPIECE BURNED THE PATIENT'S LIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL HANDPIECE 3555 DENTAL HANDPIECE AND ACCESSORIES EFA KALTENBACK & VOIGT GMBH 3555

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention