BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAUN

    MDR report key: 1010237 · Received March 7, 2008

    Report

    Report Number
    MW5005831
    Event Type
    Malfunction
    Date Received
    March 7, 2008
    Report Date
    March 7, 2008
    Manufacturer
    BRAUN
    Product Code
    JEQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BRAUN 4723 ELECTRIC TOOTHBRUSH/WATERJET ORAL HYGIENE SYSTEM. SEVERAL FINE FIBERS CLOGGED EXIT VALVE ON WATERJET. THE FIBERS APPEAR TO BE CORRODED COPPER WIRE, WHICH MAY HAVE COME FROM THE WIRES THAT CONNECT THE SWITCH ON THE WATERJET HANDLE TO THE PUMP HOUSING, AND WHICH RUN THROUGH THE CONNECTING HOSE. SMALLER PIECES OF THIS WIRE MAY NOT BE TRAPPED IN THE EXIT VALVE, AND WOULD BE FORCED AGAINST/INTO THE GUMS BY THE VELOCITY OF THE WATERJET. SHARP METALLIC FIBERS COATED WITH COOPER CORROSION MAY BE DANGEROUS. THIS PROBLEM WAS IDENTIFIED IN 2008, BUT HAS BEEN CHRONIC. DATES OF USE: SEVERAL YRS. DIAGNOSIS OR REASON FOR USE: CLEAN TEETH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAUN PERSONAL HYGIENE APPLIANCE JEQ BRAUN 4723

    Patients

    Seq Age Sex Outcome Treatment
    1