BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRASSELER

    MDR report key: 1664692 · Received April 20, 2010

    Report

    Report Number
    1032227-2010-00007
    Event Type
    Injury
    Date Received
    April 20, 2010
    Date of Event
    March 19, 2010
    Report Date
    March 24, 2010
    Manufacturer
    BRASSELER USA
    Product Code
    EJL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER EVAL SUMMARY : PRODUCT WAS RETURNED FROM CUSTOMER AND WAS EVALUATED BY COMPANY PERSONNEL. THE PRODUCT REFERENCED IN THE COMPLAINT IS A STERILE SINGLE PT / SINGLE USE DIAMOND BUR. A TOTAL OF 14 BURS WERE RETURNED FROM THE CUSTOMER. FOUR WERE USED, BUT NOT BENT. ONE WAS USED AND BENT AT THE COLOR BAND GROOVE AND WAS NOTED TO BE THE BUR INVOLVED IN THE EVENT. THE BENT AREA OF THE SHANK INDICATES THE BUR WAS USED NOT FULLY CHUCKED. THE SHANK OF THE BUR WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION. EIGHT WERE UNUSED. FOUR ITEMS FROM THE SAME MFG LOT WERE TESTED FOR NECK STRENGTH FULLY CHUCKED. ALL PASSED. TWO ITEMS FROM THE SAME MFG LOT WERE TESTED FOR NECK STRENGTH CHUCKED ONLY TO THE BAND AREA (WHERE THE BENDING WAS NOTED). BOTH FAILED. CONCLUSION: DEVICE WAS USED NOT FULLY CHUCKED.

    Description of Event or Problem · 1

    DENTAL OFFICE ADVISED THAT DURING A PROCEDURE, THE DIAMOND BUR BENT IN THE MIDDLE OF THE SHANK. THE CHANGE IN NOISE CAUSED THE PT TO JERK HIS HEAD, RESULTING IN THE DIAMOND BUR MAKING CONTACT WITH THE INSIDE OF THE CHEEK AND CUTTING THE CHEEK OPEN. THE DENTIST HAD TO F/U WITH 5 TO 7 STITCHES TO CLOSE THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRASSELER EJL BRASSELER USA 6856SU.31.021 S07812

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention