BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRAMATIC CONTRA ANGLE 23 A

    MDR report key: 1971431 · Received January 17, 2011

    Report

    Report Number
    3003637274-2011-00003
    Event Type
    Injury
    Date Received
    January 17, 2011
    Date of Event
    May 21, 2010
    Report Date
    December 13, 2010
    Manufacturer
    KAVO DENTAL GMBH
    Product Code
    EFB
    PMA / PMN Number
    K073478
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    A DENTIST WAS PERFORMING A ROUTINE PROCEDURE ON A PT USING A DENTAL ELECTRICAL HANDPIECE WHEN THE PATIENT'S UPPER LEFT CHEEK WAS BURNED BY THE HANDPIECE. HANDPIECE WAS NOT SENT IN FOR ANALYSIS. DUE TO THE AGE OF THE HANDPIECE IT IS NOT REPAIRABLE AGAIN AND HENCE THE CUSTOMER STATED THAT IT IS NOT IN USE ANYMORE. EXEMPTION NUMBER (B)(4) 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 DENTIST WAS PERFORMING A ROUTINE PROCEDURE ON A PT USING A DENTAL ELECTRICAL HANDPIECE WHEN THE PATIENT'S UPPER LEFT CHEEK WAS BURNED BY THE HANDPIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRAMATIC CONTRA ANGLE 23 A DENTAL HANDPIECE EFB KAVO DENTAL GMBH 23 A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other