BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORALBPWRPWRORALCARERFLSPRECISIONCLEAN

    MDR report key: 6185214 · Received December 19, 2016

    Report

    Report Number
    3000302531-2016-00490
    Event Type
    Malfunction
    Date Received
    December 19, 2016
    Report Date
    November 28, 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

    BRUSH OF THE HEAD ENDED UP IN THROAT [FOREIGN BODY]. BRUSH OF THE HEAD CAME OFF (AND ENDED UP IN THROAT) [DEVICE BREAKAGE]. CASE DESCRIPTION: A FEMALE CONSUMER, AGE UNSPECIFIED, REPORTED VIA E-MAIL ON 28-NOV-2016 THAT WHILE USING AN ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN ON (B)(6) 2016, THE BRUSH OF THE ORAL-B POWER ORAL CARE REFILLS PRECISION CLEAN CAME OFF AND ENDED UP IN HER THROAT. SHE STATED IT TURNED OUT OKAY BUT SHE COULD HAVE CHOKED. THE CONSUMER REPORTED SHE HAD USED THE ORAL-B ELECTRIC TOOTHBRUSH WITH BRUSH HEAD FOR YEARS TO HER FULL SATISFACTION, BUT LATELY THEY WEAR OUT MORE QUICKLY. THE CASE OUTCOME WAS RECOVERED. ON 02-DEC-2016 RECEIVED CONSUMER'S FOLLOW-UP E-MAIL: THE CONSUMER REPORTED SHE STILL HAD THE ORAL-B POWER ORAL CARE REFILL PRECISION CLEAN, WHICH WAS FROM A PACK OF 4 BRUSHES, BUT SHE NO LONGER HAD THE PACKAGING TO PROVIDE THE PRODUCTION CODE. THE CASE OUTCOME REMAINED RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836105 ORALBPWRPWRORALCARERFLSPRECISIONCLEAN TOOTHBRUSH, POWERED JEQ BRAUN GMBH WERK MARKTHEIDENFELD NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1