BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNK

    MDR report key: 3257173 · Received July 18, 2013

    Report

    Report Number
    3000302531-2013-00013
    Event Type
    Other
    Date Received
    July 18, 2013
    Date of Event
    June 15, 2013
    Report Date
    June 27, 2013
    Manufacturer
    BRAUN GMBH WERK MARKTHEIDENFELD
    Product Code
    JEQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER OR PRODUCT WAS NOT PROVIDED BY THE REPORTER THEREFORE UNABLE TO PROCEED WITH BATCH RETAIN TESTING OR PRODUCT INVESTIGATION. DEVICE NOT AVAILABLE FOR EVAL.

    Description of Event or Problem · 1

    REMOVING A CHIP FROM MY RIGHT FRONT TOOTH [TOOTH FRACTURE]. SLICED INTO MY LOWER LIP [LIP INJURY]. BOTTOM PART OF THE BRUSH HEAD CAME AWAY [DEVICE BREAKAGE]. CASE DESCRIPTION: A FEMALE CONSUMER OF UNSPECIFIED AGE USED AN ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNK 1 APPLICATION, FREQUENCY OF APPLICATIONS UNK ON UNSPECIFIED DATES. THE BOTTOM PART OF THE BRUSHHEAD CAME AWAY REVEALING THE METAL PIN. THE PIN SLICED INTO HER LOWER LIP, SHE MOVED QUICKLY IN SHOCK AND CHIPPED HER RIGHT FRONT TOOTH WITH THE PIN. SHE IS VERY UPSET BY THIS AS IT IS VISIBLE AND IS ANXIOUS WHEN BRUSHING AND EATING DUE TO THE POSSIBILITY OF UNSEEN DAMAGE. MEDICAL TREATMENT: NO INFO WAS PROVIDED. RELEVANT HISTORY: NO INFO WAS PROVIDED. CONCOMITANT MEDICATION: NO INFO WAS PROVIDED. THE OUTCOME OF THE CASE IS: NOT RECOVERED/NOT RESOLVED. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335539 ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNK POWERED TOOTHBRUSH JEQ BRAUN GMBH WERK MARKTHEIDENFELD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other