BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORALBPWRPWRORALCARERFLSPRECISIONCLEAN

    MDR report key: 6095699 · Received November 11, 2016

    Report

    Report Number
    3000302531-2016-00447
    Event Type
    Malfunction
    Date Received
    November 11, 2016
    Report Date
    October 21, 2016
    Manufacturer
    BRAUN GMBH WERK MARKTHEIDENFELD
    Product Code
    JEQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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.

    Additional Manufacturer Narrative · 1

    17-NOV-2016 PRODUCT INVESTIGATION RESULTS: REPORTER RETURNED 1 BRUSH HEAD ON 07-NOV-2016. BRUSH HEAD CONFIRMED TO BE COUNTERFEIT.

    Description of Event or Problem · 1

    BRUSH HEAD FELL APART WHEN BRUSHING TEETH [DEVICE BREAKAGE]; NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE DESCRIPTION: A MALE CONSUMER, AGE UNSPECIFIED, REPORTED VIA SOCIAL MEDIA ON 21-OCT-2016 THAT AN ORAL-B POWER ORAL CARE REFILL PRECISION CLEAN FELL APART WHILE HE WAS BRUSHING HIS TEETH WITH AN ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN NO SYMPTOMS DEVELOPED.

    Description of Event or Problem · 1

    BRUSH HEAD FELL APART WHEN BRUSHING TEETH [DEVICE BREAKAGE]; NO ADVERSE EVENT [NO ADVERSE EVENT]; PRODUCT COUNTERFEIT [PRODUCT COUNTERFEIT]. CASE DESCRIPTION: A MALE CONSUMER, AGE UNSPECIFIED, REPORTED VIA SOCIAL MEDIA ON 21-OCT-2016 THAT AN ORAL-B POWER ORAL CARE REFILL PRECISION CLEAN FELL APART WHILE HE WAS BRUSHING HIS TEETH WITH AN ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN. NO SYMPTOMS DEVELOPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748764 ORALBPWRPWRORALCARERFLSPRECISIONCLEAN TOOTHBRUSH, POWERED JEQ BRAUN GMBH WERK MARKTHEIDENFELD NOT AVAILABLE

    Patients

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