BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-12

    MDR report key: 8517118 · Received April 16, 2019

    Report

    Report Number
    9681479-2019-00002
    Event Type
    Injury
    Date Received
    April 16, 2019
    Date of Event
    March 15, 2019
    Report Date
    March 18, 2019
    Manufacturer
    W&H DENTALWERK BUERMOOS GMBH
    Product Code
    KMW
    UDI-DI
    J021300610001
    PMA / PMN Number
    K080939
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DURING A DENTAL SURGICA TREATMENT THE INSTRUMENT GOT HOT AND IT ENDED UP IN BURNING THE PATIENT'S LIP (2ND DEGREE). THE INJURY IS REVERSIBLE AND THE PATIENT IS UNDER MONITORING. AFTER EVALUATION OF THE SUSPECT DEVICE IT CAME OUT THAT THE ADVERSE EVENT OCCURED DUE TO WRONG LUBRICATION OF THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312467 S-12 SURGICAL HANDPIECE KMW W&H DENTALWERK BUERMOOS GMBH SURGICAL HANDPIECE J021300610001

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization