BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORAL-B PROFESSIONAL CARE RECHARGEABLE TOOTHBRUSH

    MDR report key: 5064165 · Received September 9, 2015

    Report

    Report Number
    3000302531-2015-00283
    Event Type
    Malfunction
    Date Received
    September 9, 2015
    Report Date
    August 10, 2015
    Manufacturer
    BRAUN GMBH WERK MARKTHEIDENFELD
    Product Code
    JEQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    METAL PIN ON THE OLD 8500 TOOTHBRUSH BROKE OFF [DEVICE BREAKAGE]. PRECISION CLEAN BRUSH HEADS DOES NOT FIT, BECAUSE SOMETHING IS STUCK INSIDE IT [DEVICE CONNECTION ISSUE]. NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE DESCRIPTION: A MALE CONSUMER REPORTED THAT THE METAL PIN ON AN ORAL-B PROFESSIONAL CARE RECHARGEABLE 8500 TOOTHBRUSH BROKE OFF, AND THE PRECISION CLEAN BRUSH HEAD DOES NOT FIT BECAUSE SOMETHING IS STUCK INSIDE IT. NO SYMPTOMS DEVELOPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595494 ORAL-B PROFESSIONAL CARE RECHARGEABLE TOOTHBRUSH POWERED TOOTHBRUSH JEQ BRAUN GMBH WERK MARKTHEIDENFELD 8500

    Patients

    Seq Age Sex Outcome Treatment
    1