BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORALBPWRPWRORALCARERFLSPROBRIGHT

    MDR report key: 6132097 · Received November 29, 2016

    Report

    Report Number
    3000302531-2016-00468
    Event Type
    Malfunction
    Date Received
    November 29, 2016
    Report Date
    October 31, 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. THE REPORTER INFORMED THE COMPANY THAT THE PRODUCT HAD BEEN DISCARDED.

    Description of Event or Problem · 1

    BRUSH HEAD SHOT LOOSE/BROKE IN MOUTH WHEN BRUSHING [DEVICE BREAKAGE]. NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE DESCRIPTION: A CONSUMER OF UNSPECIFIED AGE AND GENDER REPORTED VIA E-MAIL ON (B)(6) 2016 THAT THE ORAL-B POWER ORAL CARE REFILLS PRO BRIGHT SHOT LOOSE/BROKE IN HIS/HER MOUTH WHEN HE/SHE WAS BRUSHING WITH AN ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN. NO SYMPTOMS DEVELOPED. ON (B)(6) 2016 RECEIVED FOLLOW-UP E-MAIL FROM CONSUMER: THE CONSUMER REPORTED THAT HE/SHE IMMEDIATELY THREW AWAY THE REST OF THE BRUSHES, AND THAT HE/SHE USED A STANDARD ELECTRIC TOOTHBRUSH. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784765 ORALBPWRPWRORALCARERFLSPROBRIGHT TOOTHBRUSH, POWERED JEQ BRAUN GMBH WERK MARKTHEIDENFELD NOT AVAILABLE

    Patients

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