BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICAL HANDPIEC 3610N1

    MDR report key: 2181562 · Received July 6, 2011

    Report

    Report Number
    3003637274-2011-00036
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 14, 2011
    Manufacturer
    KAVO DENTAL GMBH
    Product Code
    EFB
    PMA / PMN Number
    K073478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS OF THE HANDPIECE DID SHOW THAT THERE HAS BEEN STILL RESIDUE OF OLD BLOOD IN THE SLEEVE OF THE HANDPIECE WHICH SHOULD BE REMOVED AFTER EACH TREATMENT DURING PROCESSING AND MAINTAINING AFTER EACH USE. AS RESULT THE BEARINGS HAVE BEEN GRINDING AND BINDING WHICH CAUSED THE HANDPIECE TO HEAT UP. REPORTED DUE TO THE 2 YEAR PRESUMPTION RULE. ISSUE OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    DURING A TREATMENT WITH A DENTAL ELECTRICAL HANDPIECE THE DENTIST RECEIVED A BURN ON HIS HAND. NOTHING WAS USED TO TREAT THE BURN AND HEALED ALREADY COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL HANDPIEC 3610N1 DENTAL HANDPIECE EFB KAVO DENTAL GMBH 3610N1

    Patients

    Seq Age Sex Outcome Treatment
    1