BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REACH TOTAL CARE PLUS WHITEN TOOTHBRUSH

    MDR report key: 2875069 · Received December 17, 2012

    Report

    Report Number
    2214133-2012-00408
    Event Type
    Malfunction
    Date Received
    December 17, 2012
    Report Date
    December 7, 2012
    Manufacturer
    SKILLMAN CONTRACT
    Product Code
    EFW
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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.

    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)(4) 2012, FROM A FEMALE CONSUMER (AGE UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING REACH TOTAL CARE PLUS WHITENING TOOTHBRUSH, FOR DENTAL CLEANING (ROUTE DENTAL, LOT NUMBER, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION SHE NOTICED THAT THE HANDLE OF THE TOOTHBRUSH BROKE AT THE WHITE GRIP PART. SHE ALSO STATED THAT THE SHE COULD ONLY READ ONE NUMBER THAT LOOKED LIKE TWO AND COULD NOT SEE ANY OTHER NUMBERS OR LETTERS ON THE TOOTHBRUSH. THE 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)(4) 2013: NO LOT NUMBER PROVIDED AND NO SAMPLE WAS RETURNED. BASED UPON AN ACCEPTABLE RELATED PRODUCT CHANGES AND MANUFACTURING/FACILITY ISSUE REVIEW, LACK OF A SAMPLE AND LOT NUMBER AND NO ADVERSE TRENDS THE COMPLAINT CANNOT BE CONFIRMED AND A ROOT CAUSE CANNOT BE DETERMINED FOR THIS COMPLAINT. MONITORING OF COMPLAINT TRENDS WILL CONTINUE. THIS REPORT WAS CONSIDERED A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013. THE LOT NUMBER OF THE DEVICE WAS UPDATED FROM UNSPECIFIED TO 13911SG S3. THIS REPORT REMAINS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013. REVIEW OF THE TRENDING DATA BY PRODUCT FAMILY REVEALED NO ADVERSE TRENDS. AN INCREASE WAS NOTED WHICH WAS ATTRIBUTED TO AN INCREASE IN SHIPMENT QUANTITY. THERE WERE NO RELATED MANUFACTURING/ FACILITY ISSUES FOUND AND THERE WERE NO CHANGES MADE TO THE DESIGN, FORMULA, PACKAGING OR LABELING FROM THE RELEASE DATE OF THE PRODUCT TO THE DATE OF MANUFACTURE OF THE LOT. ONE TOOTHBRUSH LOT 13911SG S3 WAS RECEIVED. THE TOOTHBRUSH WAS COMPLETELY BROKEN APPROXIMATELY ONE CM BELOW THE THUMB GRIP. PACKAGING WAS NOT RETURNED. THE DEFECT OBSERVED IN THE RETURNED COMPLAINT SAMPLE WAS NOT DUE TO A MANUFACTURING OCCURRENCE AND WAS MANUFACTURED ACCORDING TO THE SPECIFICATION. (B)(4). THE DEVICE HISTORY REVIEW AND VISUAL RETAIN EVALUATION FOR LOT 13911SG S3 WAS ACCEPTABLE. NO ADVERSE TRENDS WERE NOTED WITH THIS PRODUCT OR LOT. THE BREAK OCCURRED DUE TO HIGH COMPRESSION FORCES ON THE HANDLE. IT WAS VERIFIED THAT DURING THE VALIDATION OF THIS PRODUCT THE TOOTHBRUSH WAS SUBJECTED TO OVER BEND TESTING AND NO TOOTHBRUSHES BROKE. THE RETURNED TOOTHBRUSH WAS MANUFACTURED ACCORDING TO SPECIFICATION THEREFORE THE DISPOSITION OF THIS COMPLAINT WAS UNDETERMINED. AFTER RECEIVING THE FIELD SAMPLE LOT NUMBER WAS PRESENT ON THE TOOTHBRUSH. NO ADVERSE TRENDS WERE IDENTIFIED DURING THE COMPLAINT INVESTIGATION. COMPLAINT TRENDS WOULD CONTINUE TO BE MONITORED. 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) 2012, FROM A FEMALE CONSUMER (AGE UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING REACH TOTAL CARE PLUS WHITENING TOOTHBRUSH, FOR DENTAL CLEANING (ROUTE DENTAL, LOT NUMBER, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, SHE NOTICED THAT THE HANDLE OF THE TOOTHBRUSH BROKE AT THE WHITE GRIP PART. SHE ALSO STATED THAT SHE COULD ONLY READ ONE NUMBER THAT LOOKED LIKE TWO AND COULD NOT SEE ANY OTHER NUMBERS OR LETTERS ON THE TOOTHBRUSH. THE 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.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2012, FROM A FEMALE CONSUMER (AGE UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING REACH TOTAL CARE PLUS WHITENING TOOTHBRUSH, FOR DENTAL CLEANING (ROUTE DENTAL, LOT NUMBER, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION SHE NOTICED THAT THE HANDLE OF THE TOOTHBRUSH BROKE AT THE WHITE GRIP PART. SHE ALSO STATED THAT THE SHE COULD ONLY READ ONE NUMBER THAT LOOKED LIKE TWO AND COULD NOT SEE ANY OTHER NUMBERS OR LETTERS ON THE TOOTHBRUSH. THE 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: NO LOT NUMBER PROVIDED AND NO SAMPLE WAS RETURNED. BASED UPON AN ACCEPTABLE RELATED PRODUCT CHANGES AND MANUFACTURING/FACILITY ISSUE REVIEW, LACK OF A SAMPLE AND LOT NUMBER AND NO ADVERSE TRENDS THE COMPLAINT CANNOT BE CONFIRMED AND A ROOT CAUSE CANNOT BE DETERMINED FOR THIS COMPLAINT. MONITORING OF COMPLAINT TRENDS WILL CONTINUE. THIS REPORT WAS CONSIDERED A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(4) 2012, FROM A FEMALE CONSUMER (AGE UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING REACH TOTAL CARE PLUS WHITENING TOOTHBRUSH, FOR DENTAL CLEANING (ROUTE DENTAL, LOT NUMBER, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION SHE NOTICED THAT THE HANDLE OF THE TOOTHBRUSH BROKE AT THE WHITE GRIP PART. SHE ALSO STATED THAT THE SHE COULD ONLY READ ONE NUMBER THAT LOOKED LIKE TWO AND COULD NOT SEE ANY OTHER NUMBERS OR LETTERS ON THE TOOTHBRUSH. THE 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)(4) 2013 NO LOT NUMBER PROVIDED AND NO SAMPLE WAS RETURNED. BASED UPON AN ACCEPTABLE RELATED PRODUCT CHANGES AND MANUFACTURING/FACILITY ISSUE REVIEW, LACK OF A SAMPLE AND LOT NUMBER AND NO ADVERSE TRENDS THE COMPLAINT CANNOT BE CONFIRMED AND A ROOT CAUSE CANNOT BE DETERMINED FOR THIS COMPLAINT. MONITORING OF COMPLAINT TRENDS WILL CONTINUE. THIS REPORT WAS CONSIDERED A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013. THE LOT NUMBER OF THE DEVICE WAS UPDATED FROM UNSPECIFIED TO 13911SG S3. THIS REPORT REMAINS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REACH TOTAL CARE PLUS WHITEN TOOTHBRUSH TOOTHBRUSH, MANUAL EFW SKILLMAN CONTRACT RETCTHUS 13911SG S3

    Patients

    Seq Age Sex Outcome Treatment
    1