BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REACH TOTAL CARE PLUS WHITEN TOOTHBRUSH USA

    MDR report key: 2912735 · Received January 14, 2013

    Report

    Report Number
    2214133-2013-00009
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Report Date
    January 3, 2013
    Manufacturer
    SKILLMAN CONTRACT
    Product Code
    EFW
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013, FROM A CONSUMER (AGE AND GENDER UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING THE REACH TOTAL CARE PLUS WHITENING TOOTHBRUSH FOR DENTAL CLEANING (ROUTE- DENTAL, FREQUENCY, LOT NUMBER AND EXPIRATION DATE WERE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, ON (B)(6) 2013, THE CONSUMER NOTICED THAT, THE TOOTHBRUSH SNAPPED IN HALF WHILE USING IT. THIS REPORT HAD NO ADVERSE EVENT AND THE ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. THIS REPORT WAS CONSIDERED A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013: BASED UPON AN ACCEPTABLE PRODUCT AND MANUFACTURING HISTORY REVIEW, LACK OF A LOT NUMBER AND SAMPLE AND NO ADVERSE TRENDS A ROOT CAUSE CANNOT BE DETERMINED FOR THIS COMPLAINT. IF A SAMPLE AND/OR LOT NUMBER IS RECEIVED, THIS CASE WILL BE REOPENED AND INVESTIGATED ACCORDINGLY. MONITORING OF COMPLAINT TRENDS WILL CONTINUE. THIS REPORT REMAINS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013, FROM A CONSUMER (AGE AND GENDER UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING THE REACH TOTAL CARE PLUS WHITENING TOOTHBRUSH FOR DENTAL CLEANING (ROUTE- DENTAL, FREQUENCY, LOT NUMBER AND EXPIRATION DATE WERE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, ON (B)(6) 2013, THE CONSUMER NOTICED THAT, THE TOOTHBRUSH SNAPPED IN HALF WHILE USING IT. THIS REPORT HAD NO ADVERSE EVENT AND THE ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. THIS REPORT WAS CONSIDERED A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20142 REACH TOTAL CARE PLUS WHITEN TOOTHBRUSH USA TOOTHBRUSH, MANUAL EFW SKILLMAN CONTRACT RETCTHUS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1