BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRASSELER

    MDR report key: 1812406 · Received August 12, 2010

    Report

    Report Number
    1032227-2010-00015
    Event Type
    Malfunction
    Date Received
    August 12, 2010
    Report Date
    July 13, 2010
    Manufacturer
    BRASSELER USA
    Product Code
    DZA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS RETURNED FROM CUSTOMER IN UNOPENED PACKAGES AND WAS EVALUATED BY COMPANY PERSONNEL. THE PRODUCT REFERENCED IN THE COMPLAINT IS A CARBIDE SURGICAL BUR. THE LOT REFERENCED WAS PACKAGED FROM BULK LOTS 538518 AND 537193. A SAMPLE OF TWENTY (20) BURS FROM BULK LOT 538518 WERE SELECTED FROM INVENTORY. THESE BURS WERE TESTED FOR NECK STRENGTH IN ACCORDANCE WITH ISO 8325:2004. ALL SAMPLES PASSED WITH NO FAILURES. A SAMPLE OF TWENTY (20) BURS FROM BULK LOT 5387193 WERE SELECTED FROM INVENTORY. THESE BURS WERE TESTED FOR NECK STRENGTH IN ACCORDANCE WITH ISO 8325:2004. ALL SAMPLES PASSED WITH NO FAILURES. CONCLUSION: UNABLE TO DETERMINE CAUSE.

    Description of Event or Problem · 1

    DENTAL OFFICE ADVISED THE BURS ARE BREAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRASSELER DZA BRASSELER USA H33R.30.016 KE4L6

    Patients

    Seq Age Sex Outcome Treatment
    1