BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REACH TOTAL CARE PLUS WHITENING TOOTHBRUSH

    MDR report key: 3021859 · Received March 26, 2013

    Report

    Report Number
    2214133-2013-00036
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    March 19, 2013
    Manufacturer
    SKILLMAN CONTRACT
    Product Code
    EFW
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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, ONE MONTH AGO, THE CONSUMER STARTED USING REACH TOTAL CARE PLUS WHITENING TOOTHBRUSH, FOR ORAL HYGIENE (ROUTE DENTAL, LOT NUMBER 07111SG S1, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, WHILE BRUSHING, THE TOOTHBRUSH HANDLE BROKE IN HALF INTO TWO PIECES AT THE THUMB GRIP. THIS REPORT HAD NO ADVERSE EVENT AND THE ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. THIS REPORT WAS CONSIDERED AS REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(4) 2013 FROM A CONSUMER (AGE AND GENDER UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. ON AN UNSPECIFIED DATE, ONE MONTH AGO, THE CONSUMER STARTED USING REACH TOTAL CARE PLUS WHITENING TOOTHBRUSH, FOR ORAL HYGIENE (ROUTE DENTAL, LOT NUMBER 07111SG S1, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, WHILE BRUSHING, THE TOOTHBRUSH HANDLE BROKE IN HALF INTO TWO PIECES AT THE THUMB GRIP. THIS REPORT HAD NO ADVERSE EVENT AND THE ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. THIS REPORT WAS CONSIDERED AS REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013 A RETURNED SAMPLE WAS RECEIVED AND WAS VISUALLY INSPECTED AND THE TOOTHBRUSH WAS FOUND BROKEN IN HALF JUST BELOW THE THUMB GRIP. NO OTHER DEFECT WAS NOTED ON TOOTHBRUSH. THERE WERE NO MANUFACTURING OR FACILITY ATYPICAL EVENTS, DEVIATIONS OR NON-CONFORMANCES FOUND. DESIGN/FORMULA/PACKAGING/LABELING CHANGES WAS REVIEWED AND THERE WERE NO RELATED PRODUCT, PROCESS OR FACILITY CHANGES. NO DEFECTS HAVE BEEN DETECTED FOR THE EVALUATED RETAIN SAMPLE. IT WAS MANUFACTURED ACCORDING TO SPECIFICATION. ONE TOOTHBRUSH LOT 07111SG S1 WAS RECEIVED AND AS PER THE MANUFACTURER THE RETURNED TOOTHBRUSH LOT HAS BEEN MANUFACTURED ACCORDING TO THE SPECIFICATION. A REVIEW OF THE TRENDING DATA BY PRODUCT FAMILY REVEALED AN INCREASE. THIS COULD BE ATTRIBUTED TO AN INCREASE IN SHIPMENT QUANTITY. THIS COMPLAINT WAS NOT CONFIRMED BECAUSE THE EVALUATION OF THE RETURNED SAMPLE AND THE MANUFACTURING REVIEW REVEALED THAT THE ISSUE WAS NOT CAUSED BY A MANUFACTURING OCCURRENCE. BASED ON THE INFORMATION AVAILABLE, THIS DEVICE WAS USED AS INTENDED FOR TREATMENT. THE DEVICE HISTORY REVIEW AND VISUAL RETAIN EVALUATION FOR LOT 07111SG S1 BY MANUFACTURER WAS ACCEPTABLE. NO ADVERSE TRENDS HAD BEEN NOTED WITH THIS PRODUCT OR LOT. ALTHOUGH THE RETURNED SAMPLE RECEIVED WAS BROKEN, THE PRODUCT DEFECT WAS NOT DUE TO A MANUFACTURING OCCURRENCE. THE MANUFACTURER STATED THAT THE BREAK OCCURRED DUE TO HIGH COMPRESSION FORCES AT THE THINNEST POINT ON THE HANDLE AND THEY HAD VERIFIED THAT DURING THE VALIDATION OF THIS PRODUCT, THE TOOTHBRUSH WAS SUBJECTED TO OVER BEND TESTING AND NO TOOTHBRUSHES BROKE. THE MANUFACTURER CONFIRMED THE RETURNED TOOTHBRUSH WAS MANUFACTURED ACCORDING TO SPECIFICATION THEREFORE THE DISPOSITION OF THIS COMPLAINT WAS UNDETERMINED. COMPLAINT TRENDS WOULD CONTINUE TO BE MONITORED. THIS REPORT REMAINS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124426 REACH TOTAL CARE PLUS WHITENING TOOTHBRUSH TOOTHBRUSH, MANUAL EFW SKILLMAN CONTRACT 8137108922 07111SG S1

    Patients

    Seq Age Sex Outcome Treatment
    1