BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORAL-B FLEXISOFT OR PRECISION CLEAN BRUSHHEADS

    MDR report key: 5310963 · Received December 18, 2015

    Report

    Report Number
    3000302531-2015-00411
    Event Type
    Malfunction
    Date Received
    December 18, 2015
    Report Date
    November 27, 2015
    Manufacturer
    BRAUN GMBH WERK MARKTHEIDENFELD
    Product Code
    JEQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTER INFORMED THAT THE ORAL-B PRECISION CLEAN BRUSH HEAD 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

    THE HEAD OF THE ATTACHMENT BROKE, NEARLY SWALLOWED SMALL METAL PIN. NO ADVERSE EVENT. CASE DESCRIPTION: A (B)(6) MALE CONSUMER REPORTED THAT WHILE USING AN ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN THE ORAL-B BRUSHHEADS, VERSION UNKNOWN BROKE AFTER USING THEM FOR TWO DAYS, AND HE NEARLY SWALLOWED A SMALL METAL PIN. NO SYMPTOMS DEVELOPED. ON (B)(6) 2015 RECEIVED FOLLOW-UP: THE CONSUMER REPORTED THAT HE USED AN ORAL-B PRECISION CLEAN BRUSHHEAD, AND HE DISPOSED OF THE BROKEN BRUSH HEAD. HE WAS ABLE TO USE ANOTHER BRUSH HEAD FROM THE PACK, BUT HAD NOW SWITCHED TO A MANUAL TOOTHBRUSH. NO SYMPTOMS DEVELOPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838534 ORAL-B FLEXISOFT OR PRECISION CLEAN BRUSHHEADS TOOTHBRUSH, POWERED JEQ BRAUN GMBH WERK MARKTHEIDENFELD

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR