BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KS1 (SC) RD CYL 35005.31.052

    MDR report key: 12659926 · Received October 19, 2021

    Report

    Report Number
    1032227-2021-00028
    Event Type
    Malfunction
    Date Received
    October 19, 2021
    Date of Event
    September 7, 2021
    Report Date
    October 19, 2021
    Product Code
    DZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BRASSELER IS REPORTING THIS ALLEGED PRODUCT MALFUNCTION IN AN ABUNDANCE OF CAUTION. THE ALLEGATIONS OF MALFUNCTION HAVE NOT BEEN CONFIRMED DUE TO THE INABILITY OF BRASSELER TO PERFORM AN INVESTIGATION OF THE BROKEN BURS WHICH WERE NOT RETURNED BY THE CUSTOMER. BRASSELER WILL FOLLOW UP WITH A SUPPLEMENTAL REPORT IF MORE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE DOCTOR REPORTED THAT THE BURS WERE BREAKING AT THE NECK OF THE BUR ON INITIAL USE DURING A PROCEDURE. THE BURS WERE USED IN A KAVO HAND PIECE. NO BURS WERE RETURNED TO BRASSELER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1560545 KS1 (SC) RD CYL 35005.31.052 DIAMOND BUR DZP LT2MF

    Patients

    Seq Age Sex Outcome Treatment
    1