BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRASSELER USA MICRO BUR

    MDR report key: 7003244 · Received November 6, 2017

    Report

    Report Number
    2025102-2017-00005
    Event Type
    Malfunction
    Date Received
    November 6, 2017
    Date of Event
    September 21, 2017
    Report Date
    November 6, 2017
    Manufacturer
    BRASSELER U.S.A. MEDICAL, LLC
    Product Code
    GFF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY REPORT (B)(4) RECEIVED ON 10/11/2017. NO PRODUCT RETURNED.

    Description of Event or Problem · 1

    WIRE PASS DRILL BROKE IN TWO PIECES WHILE IN USE DURING THE PROCEDURE. NO ADVERSE EFFECT TO PATIENT OR STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782563 BRASSELER USA MICRO BUR WIRE PASS DRILL GFF BRASSELER U.S.A. MEDICAL, LLC 18-S1701 NN5A4

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR