BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORAL-B BRUSHHEADS, VERSION UNKNOWN

    MDR report key: 7475065 · Received May 1, 2018

    Report

    Report Number
    3000302531-2018-00117
    Event Type
    Malfunction
    Date Received
    May 1, 2018
    Report Date
    April 4, 2018
    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

    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

    DIG INTO CHEEK (MOUTH INJURY). BRUSH CAME AWAY FROM THE MOTOR UNIT, THE RESULTING SHARP EDGE MANAGED TO DIG INTO CHEEK (INJURY ASSOCIATED WITH DEVICE). BRUSH CAME AWAY FROM THE MOTOR UNIT / A SMALL METAL PIECE HAD OBVIOUSLY COME OFF (DEVICE BREAKAGE). CASE DESCRIPTION: A CONSUMER OF UNSPECIFIED AGE AND GENDER REPORTED SPONTANEOUSLY VIA E-MAIL ON (B)(6) 2018 THAT WHEN HE/SHE WAS BRUSHING HIS/HER TEETH THAT MORNING WITH AN ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN, THE ORAL-B BRUSHHEAD, VERSION UNKNOWN CAME AWAY FROM THE MOTOR UNIT (AS A SMALL METAL PIECE HAD OBVIOUSLY COME OFF) AND THE RESULTING SHARP EDGE HE/SHE MANAGED TO DIG INTO HIS/HER CHEEK. THE CASE OUTCOME WAS UNKNOWN. TREATMENT DETAILS: UNKNOWN. RELEVANT HISTORY: NONE REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317999 ORAL-B BRUSHHEADS, VERSION UNKNOWN TOOTHBRUSH, POWERED JEQ BRAUN GMBH WERK MARKTHEIDENFELD NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1