BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REACH TOTAL CARE PLUS WHITENING TOOTHBRUSH

    MDR report key: 3033081 · Received April 3, 2013

    Report

    Report Number
    2214133-2013-00038
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Report Date
    March 27, 2013
    Manufacturer
    JOHNSON & JOHNSON CONSUMER PRODUCTS
    Product Code
    EFW
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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

    THE DATE OF THIS SUBMISSION IS (B)(4) 2013. 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, IN (B)(6) 2013 THE CONSUMER STARTED USING REACH TOTAL CARE PLUS WHITENING TOOTHBRUSH FOR DENTAL CLEANING (ROUTE DENTAL, LOT NUMBER 1821501, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER USING THE TOOTHBRUSH FOR ABOUT TWO WEEKS, THE HANDLE BROKE IN HALF ABOVE THE THUMB GRIP WHERE THE HOLES WERE PUNCHED INTO THE HANDLE. 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)(6) 2013: THE LOT NUMBER OF THE DEVICE WAS UPDATED FROM 1821501 TO UNSPECIFIED. THIS REPORT REMAINS AS REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013: THE LOT NUMBER OF THE DEVICE WAS UPDATED FROM UNSPECIFIED TO 17011SG S1. THIS REPORT REMAINS AS 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, IN (B)(6) 2013 THE CONSUMER STARTED USING REACH TOTAL CARE PLUS WHITENING TOOTHBRUSH FOR DENTAL CLEANING (ROUTE DENTAL, LOT NUMBER 1821501, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER USING THE TOOTHBRUSH FOR ABOUT TWO WEEKS, THE HANDLE BROKE IN HALF ABOVE THE THUMB GRIP WHERE THE HOLES WERE PUNCHED INTO THE HANDLE. 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)(6) 2013: THE LOT NUMBER OF THE DEVICE WAS UPDATED FROM 1821501 TO UNSPECIFIED. THIS REPORT REMAINS AS REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013: THE LOT NUMBER OF THE DEVICE WAS UPDATED FROM UNSPECIFIED TO 17011SG S1. THIS REPORT REMAINS AS REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013. A DEVICE HISTORY RECORD REVIEW FOR THE TOOTHBRUSH LOT 17011SG S1 DID NOT INDICATE ANY DEVIATIONS IN THE MANUFACTURE OF THE LOT. THERE WERE NO MANUFACTURING OR FACILITY ATYPICAL EVENTS, DEVIATIONS OR NON-CONFORMANCES AND NO RELATED PRODUCT, PROCESS OR FACILITY CHANGES. A RETAIN SAMPLE WAS VISUALLY INSPECTED AND MET ALL SPECIFICATIONS. A CHANGE TO THE BASIC HANDLE MATERIAL HAD BEEN VALIDATED TO IMPROVE FLEXIBILITY AND THE RETURNED TOOTHBRUSH LOT HAD BEEN MANUFACTURED ACCORDING TO THE SPECIFICATION. BASED ON THE INFORMATION AVAILABLE, THIS DEVICE WAS USED AS INTENDED FOR TREATMENT. 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 AND THE BREAK OCCURRED WAS DUE TO HIGH COMPRESSION FORCES AT THE THINNEST POINT ON THE HANDLE. IT WAS VERIFIED THAT DURING THE VALIDATION OF THIS PRODUCT, THE TOOTHBRUSH WAS SUBJECTED TO OVERBEND TESTING AND NO TOOTHBRUSHES BROKE. DISPOSITION WAS UNDETERMINED. NO ISSUES WERE NOTED DURING THIS INVESTIGATION AND NO ADVERSE TRENDS WERE IDENTIFIED. 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) 2013 FROM A CONSUMER (AGE AND GENDER UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. ON AN UNSPECIFIED DATE, IN (B)(6) 2013, THE CONSUMER STARTED USING REACH TOTAL CARE PLUS WHITENING TOOTHBRUSH FOR DENTAL CLEANING (ROUTE DENTAL, LOT NUMBER 1821501, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER USING THE TOOTHBRUSH FOR ABOUT TWO WEEKS, THE HANDLE BROKE IN HALF ABOVE THE THUMB GRIP WHERE THE HOLES WERE PUNCHED INTO THE HANDLE. 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, IN (B)(6) 2013 THE CONSUMER STARTED USING REACH TOTAL CARE PLUS WHITENING TOOTHBRUSH FOR DENTAL CLEANING (ROUTE DENTAL, LOT NUMBER 1821501, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER USING THE TOOTHBRUSH FOR ABOUT TWO WEEKS, THE HANDLE BROKE IN HALF ABOVE THE THUMB GRIP WHERE THE HOLES WERE PUNCHED INTO THE HANDLE. 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: THE LOT NUMBER OF THE DEVICE WAS UPDATED FROM 1821501 TO UNSPECIFIED. THIS REPORT REMAINS AS REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137092 REACH TOTAL CARE PLUS WHITENING TOOTHBRUSH TOOTHBRUSH, MANUAL EFW JOHNSON & JOHNSON CONSUMER PRODUCTS 8137108922 17011SG S1

    Patients

    Seq Age Sex Outcome Treatment
    1