BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORAL-B PRECISION CLEAN BRUSHHEADS

    MDR report key: 6456572 · Received April 4, 2017

    Report

    Report Number
    3000302531-2017-00128
    Event Type
    Malfunction
    Date Received
    April 4, 2017
    Report Date
    March 6, 2017
    Manufacturer
    BRAUN GMBH WERK MARKTHEIDENFELD
    Product Code
    JEQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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

    JABBED UPPER GUM [GINGIVAL INJURY]; METAL PIECE CAME OUT OF BRUSH HEAD AND IT JABBED ME IN THE GUMS - ORAL-B POWER BRUSHHEAD [INJURY ASSOCIATED WITH DEVICE]; METAL PIECE OR PIN CAME OUT OF BRUSH HEAD, BRUSH HEAD THEN FELL APART - ORAL-B POWER BRUSHHEAD [DEVICE BREAKAGE]. CASE DESCRIPTION: A (B)(6) FEMALE CONSUMER REPORTED VIA PHONE ON 06-MAR-2017 THAT SHE BOUGHT A BRAND NEW ORAL-B RECHARGEABLE TOOTHBRUSH PRO 500 AND NEW ORAL-B POWER ORAL CARE REFILLS PRECISION CLEAN, AND A METAL PIECE OR PIN CAME OUT OF THE TOP OF THE BRUSH HEAD AND JABBED HER IN THE GUMS WHILE BRUSHING FOR THE FIFTH TIME WITH THE NEW BRUSH HEAD ON AN UNSPECIFIED DATE. THE BRUSH HEAD THEN FELL APART AND DROPPED INTO THE SINK. SHE RETRIEVED THE METAL PIECE OUT OF HER MOUTH WITH HER FINGERS, AND THE REST OF THE BRUSH HEAD WENT DOWN THE SINK DRAIN. THE CONSUMER REPORTED THE INCIDENT DID NOT REALLY HURT HER, IT JUST STARTLED HER. SHE HAD BEEN USING ORAL-B FOR YEARS AND THIS HAD NEVER HAPPENED BEFORE. SHE REPORTED THE KIND SHE USES IS PRECISION CLEAN BRUSH HEADS WITH GREEN BRISTLES IN THE MIDDLE. THE CONSUMER EXPLAINED THAT HER FRIEND BROUGHT HER A TYPE WITH WHITE BRISTLES IN THE MIDDLE TO REPLACE THE PRECISION CLEAN SHE HAD USED, BUT SHE COULD NOT USE THIS TYPE BECAUSE OF SPLINTS ON HER TEETH. THE CASE OUTCOME WAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240467 ORAL-B PRECISION CLEAN BRUSHHEADS TOOTHBRUSH, POWERED JEQ BRAUN GMBH WERK MARKTHEIDENFELD NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR ORAL-B RECHARGEABLE TOOTHBRUSH PRO 500