BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-11 LED G

    MDR report key: 4660246 · Received April 2, 2015

    Report

    Report Number
    9681479-2015-00002
    Event Type
    Injury
    Date Received
    April 2, 2015
    Date of Event
    July 22, 2014
    Report Date
    March 13, 2015
    Manufacturer
    W & H DENTALWERK BUERMOOS GMBH
    Product Code
    KMW
    PMA / PMN Number
    K080939
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE, W&H AS THE MANUFACTURER, RECEIVED THE CONCERNED INSTRUMENT IN AUGUST 2014 FOR REPAIR. AT THAT TIME, WE GOT NO INFO THAT AN INJURY OR OTHER ADVERSE EVENT HAS HAPPENED. AFTER A DETAILED ANALYSIS BY OUR SERVICE TECHS, WE FOUND OUT, THAT THE INSTRUMENT WAS VERY POLLUTED. WE HAVE ALSO INFORMED THE DENTIST ABOUT THIS FACT. THEREFORE, IT WAS NOT A PRODUCT PROBLEM BECAUSE THE PRACTICING DENTIST HAS MAINTAINED THE INSTRUMENT VERY POORLY AND NOT IN COMPLIANCE WITH W&H'S INSTRUCTIONS FOR USE. THE SPECS FOR HYGIENE AND MAINTENANCE ARE CLEARLY STATED IN W&H'S IFU (SURGICAL HANDPIECE S-11 LED G) ON PAGES 20-32.

    Description of Event or Problem · 1

    IN THE COURSE OF A DENTAL TREATMENT THE DENTIST USED A W&H S-11 LED G. DURING THE REMOVAL OF FOUR WISDOM TEETH THE PT SUFFERED A THREE DEGREE BURN ON THE RIGHT CORNER OF THE MOUTH BECAUSE THE INSTRUMENT GOT HOT. AT THE BEGINNING OF THE TREATMENT THE PT GOT A LOCAL ANESTHETICS THEREFORE SHE DID NOT FEEL ANYTHING. THE PT HAS NOT FURTHER DISEASES WHICH COULD HAVE AFFECT ON THE HEALING PROCESS. THE DENTIST PRESCRIBED PANTHENOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217439 S-11 LED G SURGICAL HANDPIECE, 76 KMW KMW W & H DENTALWERK BUERMOOS GMBH S-11 LED G

    Patients

    Seq Age Sex Outcome Treatment
    1 Other