BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORALBPWRPWRORALCARERFLSPRECISIONCLEAN

    MDR report key: 5650028 · Received May 12, 2016

    Report

    Report Number
    3000302531-2016-00217
    Event Type
    Malfunction
    Date Received
    May 12, 2016
    Report Date
    April 18, 2016
    Manufacturer
    BRAUN GMBH WERK MARKTHEIDENFELD
    Product Code
    JEQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETURN OF PRODUCT HAS BEEN REQUESTED. PRODUCT AND LOT NUMBER NOT PROVIDED BY THE REPORTER, THEREFORE UNABLE TO PROCEED WITH PRODUCT INVESTIGATION AT THIS TIME. FULL EVALUATION WILL OCCUR UPON RECEIPT OF THE RETURNED PRODUCT.

    Description of Event or Problem · 1

    TOOTHBRUSH HEADS HAVE FALLEN TO PIECES, BRUSH HEAD CAME AWAY AND LEFT METAL FRAGMENTS IN MOUTH [DEVICE BREAKAGE]; NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE DESCRIPTION: A FEMALE CONSUMER OF UNSPECIFIED AGE REPORTED THAT WHILE USING AN ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN, THE LAST 2 ORAL-B POWER ORAL CARE REFILLS PRECISION CLEAN HAD FALLEN TO PIECES WITHIN 2 OR 3 WEEKS OF USE. SHE STATED THAT ON THE MOST RECENT OCCASION, THE PRECISION BRUSH HEAD CAME AWAY AND LEFT METAL FRAGMENTS IN HER MOUTH. NO SYMPTOMS DEVELOPED. RELEVANT HISTORY: THE CONSUMER REPORTED SHE HAD USED ORAL-B ELECTRIC TOOTHBRUSHES FOR MANY YEARS, AND HAD BEEN PLEASED WITH THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305797 ORALBPWRPWRORALCARERFLSPRECISIONCLEAN TOOTHBRUSH, POWERED JEQ BRAUN GMBH WERK MARKTHEIDENFELD

    Patients

    Seq Age Sex Outcome Treatment
    1