BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORAL-B BRUSHHEADS, VERSION UNKNOWN

    MDR report key: 6185299 · Received December 19, 2016

    Report

    Report Number
    3000302531-2016-00491
    Event Type
    Malfunction
    Date Received
    December 19, 2016
    Report Date
    November 28, 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.

    Description of Event or Problem · 1

    TOOTHBRUSH HEAD BROKE OFF INTO MOUTH [DEVICE BREAKAGE]. NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE DESCRIPTION: A CONSUMER, AGE AND GENDER UNSPECIFIED, REPORTED VIA E-MAIL ON (B)(6) 2016 THAT WHILE BRUSHING HIS OR HER TEETH "THE OTHER MORNING" WITH AN ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN, THE ORAL-B BRUSHHEAD, VERSION UNKNOWN BROKE OFF INTO HIS OR HER MOUTH. NO SYMPTOMS DEVELOPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835683 ORAL-B BRUSHHEADS, VERSION UNKNOWN TOOTHBRUSH, POWERED JEQ BRAUN GMBH WERK MARKTHEIDENFELD NOT AVAILABLE

    Patients

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