BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORAL-B FLEXISOFT OR PRECISION CLEAN BRUSHHEADS

    MDR report key: 6044860 · Received October 20, 2016

    Report

    Report Number
    3000302531-2016-00411
    Event Type
    Malfunction
    Date Received
    October 20, 2016
    Report Date
    September 23, 2016
    Manufacturer
    BRAUN GMBH WERK MARKTHEIDENFELD
    Product Code
    JEQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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

    LIPS GET CAUGHT [LIP INJURY]; TOOTHBRUSH HEADS BREAK OFF IN MOUTH; (BEFORE THIS, THE BRUSHES BECOME LOOSE) [DEVICE BREAKAGE]; BRUSHES BECOME LOOSE, CAUSING LIPS TO GET CAUGHT IN BETWEEN [INJURY ASSOCIATED WITH DEVICE]; (TOOTHBRUSH HEADS BREAK OFF IN MOUTH); BEFORE THIS, THE BRUSHES BECOME LOOSE [DEVICE CONNECTION ISSUE]. CASE DESCRIPTION: A FEMALE CONSUMER, AGE UNSPECIFIED, REPORTED VIA PHONE ON 23-SEP-2016 THAT ORAL-B POWER ORAL CARE REFILLS FLEXISOFT, PACKS OF 5, BROKE OFF IN HER MOUTH. SHE EXPLAINED THAT THE BRUSHES WOULD FIRST BECOME LOOSE, CAUSING HER LIPS TO GET CAUGHT IN BETWEEN BEGINNING ON AN UNSPECIFIED DATE. THE CASE OUTCOME WAS UNKNOWN. CONCOMITANT PRODUCT: ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696602 ORAL-B FLEXISOFT OR PRECISION CLEAN BRUSHHEADS TOOTHBRUSH, POWERED JEQ BRAUN GMBH WERK MARKTHEIDENFELD NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN