BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORAL-B PRECISION CLEAN BRUSHHEADS

    MDR report key: 6717042 · Received July 17, 2017

    Report

    Report Number
    3000302531-2017-00264
    Event Type
    Malfunction
    Date Received
    July 17, 2017
    Report Date
    June 1, 2017
    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 THE RETURNED PRODUCT.

    Description of Event or Problem · 1

    BRUSH HEAD DISINTEGRATED IN MOUTH WHILE BRUSHING, PLASTIC HEAD AND METAL PIN GOT LOOSE [DEVICE BREAKAGE]; NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE DESCRIPTION:REPORT SOURCE: NON-EVENT - SPONTANEOUS. A CONSUMER OF UNSPECIFIED AGE AND GENDER REPORTED VIA PHONE ON (B)(6) 2017 THAT 2 BRUSH HEADS FROM A 4 PACK OF ORAL-B PRECISION CLEAN BRUSHHEADS HAD DISINTEGRATED IN HIS/HER MOUTH WHILE BRUSHING WITH AN ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN. THE REPORTER DESCRIBED THAT ONLY THE PLASTIC HEAD OF THE FIRST BRUSH HEAD WAS LOOSE IN HIS/HER MOUTH, AND BOTH THE METAL PIN AND PLASTIC HEAD WERE LOOSE WITH THE SECOND BRUSH HEAD. THEY WERE NOT SWALLOWED AND NO SYMPTOMS DEVELOPED. THE CONSUMER REPORTED HE/SHE HAD PREVIOUSLY USED PRECISION CLEAN BRUSH HEADS. RELEVANT HISTORY: NONE REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499917 ORAL-B PRECISION CLEAN BRUSHHEADS TOOTHBRUSH, POWERED JEQ BRAUN GMBH WERK MARKTHEIDENFELD NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1