BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORAL-B FLEXISOFT OR PRECISION CLEAN BRUSHHEADS

    MDR report key: 5242374 · Received November 23, 2015

    Report

    Report Number
    3000302531-2015-00375
    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 BRUSHHEADS ARE COMING LOOSE [DEVICE BREAKAGE]. SPINNING BRUSHHEADS ARE COMING LOOSE AND NIPPING INSIDE OF MOUTH [INJURY ASSOCIATED WITH DEVICE]. CASE DESCRIPTION: A CONSUMER REPORTED THAT WHILE HER HUSBAND USED AN ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN THE SPINNING HEAD OF THE ORAL-B PRECISION CLEAN BRUSHHEAD CAME LOOSE AND NIPPED THE INSIDE OF HIS MOUTH. THE CASE OUTCOME WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775078 ORAL-B FLEXISOFT OR PRECISION CLEAN BRUSHHEADS TOOTHBRUSH, POWERED JEQ BRAUN GMBH WERK MARKTHEIDENFELD

    Patients

    Seq Age Sex Outcome Treatment
    1