BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMFORTDRIVE 200XDR

    MDR report key: 1971405 · Received January 10, 2011

    Report

    Report Number
    3003637274-2010-00052
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 16, 2010
    Manufacturer
    KAVO DENTAL GMBH
    Product Code
    EFB
    PMA / PMN Number
    K080677
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    A PT RECEIVED A BURN ON THE INNER RIGHT CORNER OF THE LIP WHILE DENTIST WAS PERFORMING A STANDARD TREATMENT WITH ELECTRICAL HANDPIECE. NO OINTMENT OR MEDICATION WAS GIVEN TO PT AND DID HEAL ON HER OWN. THE PRODUCT EVALUATION DID SHOW, THAT THE PRODUCT HAS NO PROBLEM OR MALFUNCTION. PROBLEM WAS A WRONG HANDLING BY USER. EXEMPTION NUMBER E2010020 KAVO DENTAL (B)(4) (THE MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF KAVO DENTAL (B)(4) (THE IMPORTER).

    Description of Event or Problem · 1

    A PT RECEIVED A BURN ON THE INNER RIGHT CORNER OF THE LIP WHILE DENTIST WAS PERFORMING A STANDARD TREATMENT WITH ELECTRICAL HANDPIECE. NO OINTMENT OR MEDICATION WAS GIVEN TO PT AND DID HEAL ON HER OWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMFORTDRIVE 200XDR DENTAL HANDPIECE EFB KAVO DENTAL GMBH 200XDR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other