BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORALBPWRPWRORALCARERFLSPRECISIONCLEAN

    MDR report key: 5636843 · Received May 6, 2016

    Report

    Report Number
    3000302531-2016-00205
    Event Type
    Malfunction
    Date Received
    May 6, 2016
    Report Date
    April 11, 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

    METAL PIN WITHIN THE BRUSH HEAD FELL OUT INSIDE MOUTH [DEVICE BREAKAGE], NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE DESCRIPTION: A FEMALE CONSUMER, AGE UNSPECIFIED, REPORTED THAT WHILE USING AN ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN ON AN UNSPECIFIED DATE, A PIN FROM WITHIN THE ORAL-B POWER ORAL CARE REFILLS PRECISION CLEAN FELL OUT INSIDE HER MOUTH. SHE REPORTED THAT WHEN USING A DIFFERENT PRECISION CLEAN BRUSH HEAD ON (B)(6) 2016, SHE AGAIN FOUND A METAL PIN HER MOUTH. NO SYMPTOMS DEVELOPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293173 ORALBPWRPWRORALCARERFLSPRECISIONCLEAN TOOTHBRUSH, POWERED JEQ BRAUN GMBH WERK MARKTHEIDENFELD

    Patients

    Seq Age Sex Outcome Treatment
    1