BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORAL-B PRECISION CLEAN BRUSHHEADS

    MDR report key: 5393858 · Received January 27, 2016

    Report

    Report Number
    3000302531-2016-00025
    Event Type
    Malfunction
    Date Received
    January 27, 2016
    Report Date
    December 28, 2015
    Manufacturer
    BRAUN GMBH WERK MARKTHEIDENFELD
    Product Code
    JEQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONSUMER INFORMED THAT THE PRODUCT HAD BEEN DISCARDED. PRODUCT AND LOT NUMBER NOT PROVIDED BY THE REPORTER, THEREFORE UNABLE TO PROCEED WITH PRODUCT INVESTIGATION AT THIS TIME.

    Description of Event or Problem · 1

    TOP OF THE HEAD FELL OFF IN MOUTH ALONG WITH THE TINY METAL SCREW; TOOTHBRUSH HEAD FELL APART [DEVICE BREAKAGE]. NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE DESCRIPTION: A (B)(6) FEMALE CONSUMER REPORTED THAT WHILE USING AN ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN ON (B)(6) 2015, THE TOP OF THE ORAL-B PRECISION CLEAN BRUSHHEAD FELL OFF IN HER MOUTH ALONG WITH THE TINY METAL SCREW. SHE STATED SHE NEARLY SWALLOWED IT. NO SYMPTOMS DEVELOPED. (B)(6) 2015 RECEIVED FOLLOW-UP: THE CONSUMER REPORTED THE TOOTHBRUSH HEAD FELL APART IN HER MOUTH. NO SYMPTOMS DEVELOPED. (B)(6) 2016 RECEIVED FOLLOW-UP: THE CONSUMER REPORTED HAD PURCHASED THE ORAL-B PRECISION CLEAN BRUSHHEADS 2/ PACK THREE WEEKS BEFORE CHRISTMAS, AND SHE NO LONGER HAD THE PRODUCT. NO SYMPTOMS DEVELOPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53809 ORAL-B PRECISION CLEAN BRUSHHEADS ORAL-B PRECISION CLEAN BRUSHHEADS JEQ BRAUN GMBH WERK MARKTHEIDENFELD

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR