BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORAL-B DUALACTION BRUSHHEADS

    MDR report key: 6101515 · Received November 15, 2016

    Report

    Report Number
    3000302531-2016-00454
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Report Date
    August 17, 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 RETURNED PRODUCT.

    Description of Event or Problem · 1

    BLEEDING - INSIDE OF MOUTH [MOUTH HAEMORRHAGE]; SCRAP, SCRATCHING - INSIDE OF MOUTH [MOUTH INJURY]; SORES - BEHIND BOTTOM LIP [CHEILITIS]; SORES (ULCER LIKE FEELING) INSIDE OF MOUTH [STOMATITIS]; SQUARE BIT CAME OFF BRUSHHEAD / TOOTHBRUSH HEAD HAS COME ABOUT; BROKE [DEVICE BREAKAGE]; TOOTHBRUSH HEAD HAS COME ABOUT AND SCRATCHED MOUTH, SQUARE BIT CAME OFF [INJURY ASSOCIATED WITH DEVICE]. CASE DESCRIPTION: A (B)(6) MALE CONSUMER REPORTED VIA PHONE ON 17-AUG-2016 THAT SOMETHING HAD HAPPENED WITH HIS ORAL-B DUALACTION BRUSHHEAD. HE EXPLAINED THAT HE FELT SOME SCRATCHING/SCRAP IN HIS MOUTH AND BLOOD STARTED COMING OUT ON (B)(6) 2016. HE TOOK IT OUT OF HIS MOUTH AND SAW THAT THE TOOTHBRUSH HEAD HAD COME ABOUT AND SCRATCHED HIS MOUTH, NOTING THAT IT WAS THE SQUARE BIT OF THE BRUSH HEAD THAT HAD COME OFF. THE CONSUMER ASSERTED THAT HE HADN'T DROPPED THE TOOTHBRUSH EITHER SO DIDN'T KNOW HOW IT COULD HAVE BROKEN. HE STATED THAT HE THOUGHT THE BRUSH HEAD HAD BEEN IN USE SINCE THE START OF (B)(6) 2016. HE STATED THAT IT WASN'T BLEEDING FOR THAT LONG, AND NOW HE FELT LIKE HE HAD SORES (ULCER LIKE FEELING) ON THE INSIDE OF HIS MOUTH AND BEHIND HIS BOTTOM LIP; THE SCRATCHING/SCRAP ON THE INSIDE OF HIS MOUTH AND THE BLEEDING RECOVERED ON (B)(6) 2016. PRODUCT USE WAS WITHDRAWN ON (B)(6) -2016. THE CONSUMER STATED THAT THIS AS NOT THE FIRST TIME THAT HE HAD USED THESE PARTICULAR BRUSH HEADS. HE STATED THAT HE DIDN'T HAVE ANY OTHERS LEFT, BUT WAS ONTO THE "CIRCLE ONES" NOW. THE CASE OUTCOME WAS IMPROVED. CONCOMITANT PRODUCT: ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED. ON 17-AUG-2016 RECEIVED CONSUMER'S FOLLOW-UP E-MAIL: THE CONSUMER REPORTED THAT HIS TOOTHBRUSH WAS A TYPE 3709. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755474 ORAL-B DUALACTION BRUSHHEADS TOOTHBRUSH, POWERED JEQ BRAUN GMBH WERK MARKTHEIDENFELD NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR ORAL-B RECHARGEABLE TOOTHBRUSH TYPE 3709