BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORAL-B PRECISION CLEAN BRUSHHEADS

    MDR report key: 6853367 · Received September 8, 2017

    Report

    Report Number
    3000302531-2017-00333
    Event Type
    Malfunction
    Date Received
    September 8, 2017
    Report Date
    August 11, 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.

    Additional Manufacturer Narrative · 1

    ON 26-SEP-2017 PRODUCT INVESTIGATION RESULTS: THE REPORTER RETURNED TOOTHBRUSH HEAD ON 04-SEP-2017. TOOTHBRUSH HEAD CONFIRMED TO BE COUNTERFEIT.

    Description of Event or Problem · 1

    PIECE OF METAL CAME OUT OF THE HEAD DURING BRUSHING, BROKEN HEAD [DEVICE BREAKAGE]. NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE DESCRIPTION: REPORT SOURCE: NON-EVENT - SPONTANEOUS. A CONSUMER OF UNSPECIFIED AGE AND GENDER REPORTED VIA E-MAIL ON (B)(6) 2017 THAT ON THE FIRST USE OF A NEW ORAL-B PRECISION CLEAN BRUSH-HEAD, PIECE OF METAL CAME OUT OF THE HEAD DURING BRUSHING. NO SYMPTOMS WERE REPORTED. RELEVANT HISTORY: NONE REPORTED. CONCOMITANT PRODUCT: ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED. ON (B)(6) 2017 CONSUMER FOLLOW-UP VIA E-MAIL: THE CONSUMER REPORTED THE PRECISION CLEAN BRUSH HEADS WERE PURCHASED IN BULK, ONLINE, SOME TIME AGO. THE CONSUMER REPORTED THE LOGO ON THE BRUSH HEAD LOOKED GREY, AND IT DOES NOT SCRATCH OFF. NO FURTHER INFORMATION WAS PROVIDED. ON (B)(6) 2017 CONSUMER FOLLOW-UP VIA E-MAIL: THE CONSUMER REPORTED THE BROKEN BRUSH HEAD WOULD BE SENT TO THE COMPANY. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    PIECE OF METAL CAME OUT OF THE HEAD DURING BRUSHING, BROKEN HEAD [DEVICE BREAKAGE]. NO ADVERSE EVENT [NO ADVERSE EVENT]. PRODUCT COUNTERFEIT [PRODUCT COUNTERFEIT]. CASE DESCRIPTION: REPORT SOURCE: NON-EVENT - SPONTANEOUS. A CONSUMER OF UNSPECIFIED AGE AND GENDER REPORTED VIA E-MAIL ON (B)(6) 2017 THAT ON THE FIRST USE OF A NEW ORAL-B PRECISION CLEAN BRUSHHEAD, PIECE OF METAL CAME OUT OF THE HEAD DURING BRUSHING. NO SYMPTOMS WERE REPORTED. RELEVANT HISTORY: NONE REPORTED. CONCOMITANT PRODUCT: ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED. ON 14-AUG-2017 CONSUMER FOLLOW-UP VIA E-MAIL: THE CONSUMER REPORTED THE PRECISION CLEAN BRUSH HEADS WERE PURCHASED IN BULK, ONLINE, SOME TIME AGO. THE CONSUMER REPORTED THE LOGO ON THE BRUSH HEAD LOOKED GREY, AND IT DOES NOT SCRATCH OFF. NO FURTHER INFORMATION WAS PROVIDED. ON 15-AUG-2017 CONSUMER FOLLOW-UP VIA E-MAIL: THE CONSUMER REPORTED THE BROKEN BRUSH HEAD WOULD BE SENT TO THE COMPANY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633294 ORAL-B PRECISION CLEAN BRUSHHEADS TOOTHBRUSH, POWERED JEQ BRAUN GMBH WERK MARKTHEIDENFELD C636

    Patients

    Seq Age Sex Outcome Treatment
    1