BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORAL-B BRUSHHEADS, VERSION UNKNOWN

    MDR report key: 8883410 · Received August 12, 2019

    Report

    Report Number
    3000302531-2019-00144
    Event Type
    Malfunction
    Date Received
    August 12, 2019
    Report Date
    July 16, 2019
    Manufacturer
    BRAUN GMBH WERK MARKTHEIDENFELD
    Product Code
    JEQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT RETURN WAS NOT RECEIVED. PRODUCT RETURN WAS REQUESTED. FULL EVALUATION WILL OCCUR UPON RECEIPT OF RETURNED PRODUCT.

    Description of Event or Problem · 1

    BRUSH HEAD STUCK UNDER TONGUE, STUCK IN BETWEEN MOLAR AND CHEEKS [FOREIGN BODY IN GASTROINTESTINAL TRACT]. ALMOST CHOKING [CHOKING SENSATION]. TOP PART CAME OFF BRUSH HEAD IN MOUTH [DEVICE BREAKAGE]. CASE DESCRIPTION: CONSUMER CALLED STATING THE TOP PART OF THE BRUSH HEAD CAME OFF WHILE BRUSHING AND POPPED INTO HIS MOUTH. NO SERIOUS INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679012 ORAL-B BRUSHHEADS, VERSION UNKNOWN TOOTHBRUSH, POWERED JEQ BRAUN GMBH WERK MARKTHEIDENFELD NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR