BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORAL-B FLEXISOFT OR PRECISION CLEAN BRUSHHEADS

    MDR report key: 5242353 · Received November 23, 2015

    Report

    Report Number
    3000302531-2015-00374
    Event Type
    Malfunction
    Date Received
    November 23, 2015
    Report Date
    October 30, 2015
    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

    NIPPING INSIDE OF MOUTH [MOUTH INJURY]. NIPPED - LIPS [LIP INJURY]. SPINNING BRUSHHEAD COMING LOOSE AND NIPPING INSIDE OF MOUTH [INJURY ASSOCIATED WITH DEVICE]. SPINNING BRUSHHEAD COMING LOOSE; SMALL PIECE OF PLASTIC IN MOUTH FROM BRUSHHEAD [DEVICE BREAKAGE]. CASE DESCRIPTION: AN ADULT FEMALE CONSUMER REPORTED THAT WHILE USING AN ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN THE SPINNING HEADS OF TWO ORAL-B PRECISION CLEAN BRUSHHEADS CAME LOOSE AND NIPPED THE INSIDE OF HER MOUTH. A SMALL PIECE OF PLASTIC CAME OFF IN HER MOUTH AS WELL. THE CASE OUTCOME WAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772715 ORAL-B FLEXISOFT OR PRECISION CLEAN BRUSHHEADS TOOTHBRUSH, POWERED JEQ BRAUN GMBH WERK MARKTHEIDENFELD

    Patients

    Seq Age Sex Outcome Treatment
    1