BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORALBPWRPWRORALCARERFLSPRECISIONCLEAN

    MDR report key: 6066665 · Received October 31, 2016

    Report

    Report Number
    3000302531-2016-00424
    Event Type
    Malfunction
    Date Received
    October 31, 2016
    Report Date
    October 3, 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.

    Additional Manufacturer Narrative · 1

    PRODUCT INVESTIGATION RESULTS: REPORTER RETURNED ONE TOOTHBRUSH HEAD ON (B)(6) 2016. TOOTHBRUSH HEAD CONFIRMED TO BE COUNTERFEIT.

    Description of Event or Problem · 1

    BRUSH HEAD HAS COME OFF IN MOUTH [DEVICE BREAKAGE]; NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE DESCRIPTION: A FEMALE CONSUMER OF UNSPECIFIED AGE REPORTED VIA PHONE ON 03-OCT-2016 THAT SHE PURCHASED A PACK OF 4 ORAL-B POWER ORAL CARE REFILLS PRECISION CLEAN. SHE DESCRIBED THAT THE SECOND BRUSH HEAD SHE USED CAME OFF IN HER MOUTH; SHE NOTED THAT SHE HAD ONLY PUT THE BRUSH HEAD ON THE ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN ON (B)(6) 2016. SHE STATED THAT THE FIRST BRUSH HEAD FROM THE PACKAGE DIDN'T ROTATE SO SHE DISCARDED IT. THIS WAS NOT THE FIRST TIME THAT SHE HAD USED THESE PARTICULAR BRUSH HEADS. NO SYMPTOMS DEVELOPED.

    Description of Event or Problem · 1

    BRUSH HEAD HAS COME OFF IN MOUTH [DEVICE BREAKAGE]. NO ADVERSE EVENT [NO ADVERSE EVENT]. PRODUCT COUNTERFEIT [PRODUCT COUNTERFEIT]. CASE DESCRIPTION: A FEMALE CONSUMER OF UNSPECIFIED AGE REPORTED VIA PHONE ON (B)(6) 2016 THAT SHE PURCHASED A PACK OF 4 ORAL-B POWER ORAL CARE REFILLS PRECISION CLEAN. SHE DESCRIBED THAT THE SECOND BRUSH HEAD SHE USED CAME OFF IN HER MOUTH; SHE NOTED THAT SHE HAD ONLY PUT THE BRUSH ON (B)(6) 2016. SHE STATED THAT THE FIRST BRUSH HEAD FROM THE PACKAGE DIDN'T ROTATE SO SHE DISCARDED IT. THIS WAS NOT THE FIRST TIME THAT SHE HAD USED THESE PARTICULAR BRUSH HEADS. NO SYMPTOMS DEVELOPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718871 ORALBPWRPWRORALCARERFLSPRECISIONCLEAN TOOTHBRUSH, POWERED JEQ BRAUN GMBH WERK MARKTHEIDENFELD NOT AVAILABLE

    Patients

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