BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORAL-B DUALACTION BRUSHHEADS

    MDR report key: 6148271 · Received December 6, 2016

    Report

    Report Number
    3000302531-2016-00477
    Event Type
    Malfunction
    Date Received
    December 6, 2016
    Report Date
    November 7, 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

    ON 16-DEC-2016 PRODUCT INVESTIGATION RESULTS: REPORTER RETURNED 1 TOOTHBRUSH HEAD ON (B)(6) 2016. THE RESULT OF THE ANALYSIS DONE WITH THE CONSUMER RETURN SHOWED THAT WEAR LED TO THE REPORTED ISSUE. NO MANUFACTURING FAULT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    RETURN OF PRODUCT HAS BEEN REQUESTED. REPORTER RETURNED 1 BRUSH HEAD ON 15-NOV-2016. PRODUCT INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    CHOKED [CHOKING]; LOWER SQUARE BRUSH BROKE OFF INSIDE MOUTH - ORAL-B DUALACTION BRUSHHEAD [DEVICE BREAKAGE]. CASE DESCRIPTION: A FEMALE CONSUMER, AGE UNSPECIFIED, REPORTED VIA E-MAIL ON (B)(6) 2016 THAT THE "LOWER SQUARE BRUSH" OF AN ORAL-B DUALACTION BRUSHHEAD BROKE OFF INSIDE HER MOUTH WHILE BRUSHING HER TEETH WITH AN ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN ON AN UNSPECIFIED DATE, AND SHE CHOKED AND NEARLY SWALLOWED IT. SHE HAD BOUGHT THE PACK OF TOOTHBRUSH HEADS ABOUT SIX MONTHS AGO. THE CASE OUTCOME WAS RECOVERED.

    Description of Event or Problem · 1

    CHOKED [CHOKING]. LOWER SQUARE BRUSH BROKE OFF INSIDE MOUTH - ORAL-B DUALACTION BRUSHHEAD [DEVICE BREAKAGE]. CASE DESCRIPTION: A FEMALE CONSUMER, AGE UNSPECIFIED, REPORTED VIA E-MAIL ON (B)(6) 2016 THAT THE "LOWER SQUARE BRUSH" OF AN ORAL-B DUALACTION BRUSHHEAD BROKE OFF INSIDE HER MOUTH WHILE BRUSHING HER TEETH WITH AN ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN ON AN UNSPECIFIED DATE, AND SHE CHOKED AND NEARLY SWALLOWED IT. SHE HAD BOUGHT THE PACK OF TOOTHBRUSH HEADS ABOUT SIX MONTHS AGO. THE CASE OUTCOME WAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798475 ORAL-B DUALACTION BRUSHHEADS TOOTHBRUSH, POWERED JEQ BRAUN GMBH WERK MARKTHEIDENFELD I426

    Patients

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