BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AHP-77C 1:2 ANGLED HANDPIECE

    MDR report key: 1737938 · Received June 23, 2010

    Report

    Report Number
    MW5016481
    Event Type
    Injury
    Date Received
    June 23, 2010
    Date of Event
    June 10, 2010
    Report Date
    June 23, 2010
    Manufacturer
    NSK NAKANISHI
    Product Code
    EFB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WE ARE A DISTRIBUTOR OF THIS DENTAL HANDPIECE THAT CAUSED THIS INJURY TO A YOUNG MAN. THE MFR IS NSK NAKANISHI WITH MFG PLANT AND HEADQUARTERS IN (B)(6). WE HAVE REPORTED THIS TO THEM AS WELL. AN ORAL SURGEON IN (B)(6) WAS USING AN NSK DENTAL ORAL SURGICAL HANDPIECE, NSK PRODUCT NUMBER SGA-E26, TO SECTION A WISDOM TOOTH FOR EXTRACTION. "THE LAST SEGMENT OF THE DRILL HEATED UP DURING THE PROCEDURE AND CAUSED A SECOND DEGREE BURN TO THE CORNER OF THE LOWER LIP CROSSING THE VERMILLION BORDER. THE PT WAS SUBSEQUENTLY SEEN BY TWO DERMATOLOGISTS FOR EVAL AND TREATMENT." DIAGNOSIS OR REASON FOR USE: USED TO SECTION WISDOM TOOTH FOR EXTRACTION. EVENT ABATED AFTER USE: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AHP-77C 1:2 ANGLED HANDPIECE DENTAL ORAL SURGERY HANDPIECE EFB NSK NAKANISHI SGA-E26

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other DENTAL ORAL SURGERY HANDPIECE