BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORAL-B CROSSACTION POWER TOOTHBRUSH (NOT APPLICABLE) TOOTHBRUSH 1APPLIC

    MDR report key: 1914503 · Received November 30, 2010

    Report

    Report Number
    9710651-2010-00001
    Event Type
    Other
    Date Received
    November 30, 2010
    Report Date
    November 2, 2010
    Manufacturer
    BRAUN DE MEXICO Y CIA DE C.V.
    Product Code
    JEQ
    PMA / PMN Number
    (US) OTC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    REQUESTED PRODUCT RETURN ON (B)(4)-2010. TO DATE, THE REPORTER HAS NOT RETURNED THE PRODUCT; THEREFORE, UNABLE TO PROCEED WITH PRODUCT INVESTIGATION.

    Description of Event or Problem · 1

    TOP NERVE OF FINGER SEVERED [PERIPHERAL NERVE INJURY]. CUT FINGER ON ORAL-B BRUSHHEAD WHILE REMOVING IT FROM TOOTHBRUSH [SKIN LACERATION]. CASE DESCRIPTION: A CONSUMER REPORTED THAT THEY, AN ADULT MALE AGE UNSPECIFIED, CUT THEIR FINGER WHILE TRYING TO PULL OFF THE BRUSHHEAD THAT HAD BEEN ON THEIR ORAL-B CROSS ACTION POWER TOOTHBRUSH FOR AT LEAST A MONTH. THE CASE OUTCOME WAS UNK. HE MENTIONED THAT THE BRUSHHEAD WAS STUCK AND CRUSTED OVER WITH TOOTHPASTE ON THE INSIDE BECAUSE HE DOES NOT TAKE IT APART AND RINSE IT AFTER EACH USE. NO FURTHER INFORMATION WAS PROVIDED. ON (B)(6)-2010, RECEIVED CONSUMER'S FOLLOW-UP E-MAIL: THE CONSUMER REPORTED THAT THE CUT WAS DEEP AND HAD CAUSED THE TOP NERVE OF HIS FINGER TO BE SEVERED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORAL-B CROSSACTION POWER TOOTHBRUSH (NOT APPLICABLE) TOOTHBRUSH 1APPLIC NONE JEQ BRAUN DE MEXICO Y CIA DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other