BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORAL-B BRUSHHEADS, VERSION UNKNOWN

    MDR report key: 6166983 · Received December 12, 2016

    Report

    Report Number
    3000302531-2016-00485
    Event Type
    Malfunction
    Date Received
    December 12, 2016
    Report Date
    November 15, 2016
    Manufacturer
    BRAUN GMBH WERK MARKTHEIDENFELD
    Product Code
    JEQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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

    POKED IN MOUTH/CHEEK [MOUTH INJURY]. HURT MOUTH [ORAL PAIN]. BRUSH HEAD CAME OFF IN MOUTH AND POKED IN CHEEK/MOUTH, THINK IT WAS LITTLE METAL PIECE THAT POKED - ORAL B TOOTHBRUSH [INJURY ASSOCIATED WITH DEVICE]. BRUSH HEAD CAME OFF, LITTLE METAL PIECE, CRACK IN THAT PIECE - ORAL B TOOTHBRUSH [DEVICE BREAKAGE]. CASE DESCRIPTION: A FEMALE CONSUMER, AGE (B)(6), REPORTED VIA PHONE ON (B)(6) 2016 THAT WHILE USING A ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN THAT MORNING, THE ORAL-B BRUSHHEAD, VERSION UNKNOWN CAME OFF IN HER MOUTH AND POKED HER IN HER CHEEK/MOUTH. SHE STATED SHE HAD THE ORAL-B TOOTHBRUSH FOR 10 YEARS, AND IT ACTUALLY HURT HER MOUTH. SHE THOUGHT IT WAS THE LITTLE METAL PIECE THAT POKED HER; IT LOOKED LIKE THERE WAS A CRACK IN THAT PIECE. SHE STATED SHE PLACED A NEW REFILL ON THE TOOTHBRUSH AND IT SEEMED TO HOLD TOGETHER, BUT SHE HAD NOT USED IT YET. THE CONSUMER REPORTED SHE HAD USED THE PRODUCT TWICE A DAY. THE CASE OUTCOME WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818836 ORAL-B BRUSHHEADS, VERSION UNKNOWN TOOTHBRUSH, POWERED JEQ BRAUN GMBH WERK MARKTHEIDENFELD NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN