BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-11 L G

    MDR report key: 5198219 · Received October 30, 2015

    Report

    Report Number
    9681479-2015-00004
    Event Type
    Injury
    Date Received
    October 30, 2015
    Date of Event
    October 15, 2015
    Report Date
    October 30, 2015
    Manufacturer
    W & H DENTALWERK BUERMOOS GMBH
    Product Code
    KMW
    PMA / PMN Number
    K080939
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING A NORMAL ROOT CANAL TREATMENT THE INSTRUMENT GOT HOT AND THE PATIENT SUFFERED A THIRD DEGREE BURN ON HER LIPS. HOWEVER, THE INJURY WILL BE PRESUMABLY REVERSIBLE AND THE PATIENT DO NOT REQUIRE ANY SURGICAL OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721510 S-11 L G SURGICAL HANDPIECE KMW W & H DENTALWERK BUERMOOS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other