BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORAL-B RECHARGEABLE TOOTHBRUSH VERSION UNK

    MDR report key: 1981409 · Received December 13, 2010

    Report

    Report Number
    3000302531-2009-00001
    Event Type
    Other
    Date Received
    December 13, 2010
    Report Date
    February 18, 2009
    Manufacturer
    BRAUN GMBH WERK MARKTHEIDENFELD
    Product Code
    JEQ
    PMA / PMN Number
    (KR) OTC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, PRODUCT DETAILS INCLUDING LOT NUMBER WAS NOT PROVIDED BY REPORTER; THEREFORE, UNABLE TO PROCEED WITH BATCH RETAIN TESTING OR PRODUCT INVESTIGATION.

    Description of Event or Problem · 1

    CASE DESCRIPTION: A MGR FROM A HOME SHOPPING CORP REPORTED THAT A CONSUMER REPORTED TO THEM THAT THEIR SON, AGE UNSPECIFIED, USED AN ORAL-B POWER (RECHARGEABLE) TOOTHBRUSH VERSION UNK AND REPORTED THAT "A METAL PART FROM THE TOOTHBRUSH APPARENTLY HIT THE CHILD'S FACE AND THE HOSPITAL GAVE THE DIAGNOSIS OF BLOOD POISONING". THE CASE OUTCOME WAS UNK. NO FURTHER INFORMATION WAS PROVIDED. HOSPITAL GAVE THE DIAGNOSIS BLOOD POISONING [SEPSIS]. METAL PART FROM ORAL B RECHARGEABLE TOOTHBRUSH APPARENTLY HIT HIS FACE [FACE INJURY].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORAL-B RECHARGEABLE TOOTHBRUSH VERSION UNK NONE JEQ BRAUN GMBH WERK MARKTHEIDENFELD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other