BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REACH BY DESIGN TOOTHBRUSH/ULTRACLEAN

    MDR report key: 2893928 · Received January 3, 2013

    Report

    Report Number
    2214133-2013-00002
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Report Date
    December 18, 2012
    Manufacturer
    SKILLMAN CONTRACT
    Product Code
    EFW
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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

    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.

    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) 2012, FROM A CONSUMER (AGE AND GENDER UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING REACH ADVANCED DESIGN TOOTHBRUSH, FOR DENTAL CLEANING (ROUTE DENTAL, LOT NUMBER, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER THREE WEEKS OF USE, THE TOOTHBRUSH BROKE. THIS REPORT HAD NO ADVERSE EVENT AND THE ACTION TAKEN WITH THE DEVICE UNKNOWN. THIS REPORT WAS CONSIDERED A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013: NO LOT NUMBER REPORTED AND NO SAMPLE WAS RETURNED. 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. 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 CONSUMER (AGE AND GENDER UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING REACH ADVANCED DESIGN TOOTHBRUSH, FOR DENTAL CLEANING (ROUTE DENTAL, LOT NUMBER, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER THREE WEEKS OF USE, THE TOOTHBRUSH BROKE. THIS REPORT HAD NO ADVERSE EVENT AND THE ACTION TAKEN WITH THE DEVICE UNKNOWN. THIS REPORT WAS CONSIDERED A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013 NO LOT NUMBER REPORTED AND NO SAMPLE WAS RETURNED. 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. 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 WAS UPDATED FROM UNSPECIFIED TO 0149SGS2. THIS REPORT REMAINS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013 THE DEVICE NAME WAS CHANGED FROM REACH ADVANCED DESIGN TOOTHBRUSH TO REACH BY DESIGN TOOTHBRUSH. A REVIEW OF THE TRENDING DATA BY PRODUCT FAMILY FOR COMPLAINTS REVEALED NO ADVERSE TRENDS. AN INCREASE HAS BEEN NOTED. THIS COULD BE ATTRIBUTED TO AN INCREASE IN SHIPMENT QUANTITY AS WELL AS A CALLER REPORTING A QUANTITY OF TWO. NO LOT TREND HAD BEEN NOTED AND COMPLAINT NUMBERS HAD SINCE DECREASED. DEVICE HISTORY REVIEW WAS ACCEPTABLE. THERE WERE NO RELATED MANUFACTURING /FACILITY ISSUES FOUND AND THERE WERE NO CHANGES MADE TO THE DESIGN, FORMULA, PACKAGING OR LABELING WITHIN THE REVIEW PERIOD PRIOR TO THE DATE OF MANUFACTURE OF THE LOT. RETAIN SAMPLE WAS EVALUATED AND MET SPECIFICATION. ONE TOOTHBRUSH, LOT 0149SGS2, WAS RECEIVED. THIS BRUSH WAS MANUFACTURED ACCORDING TO SPECIFICATION AND THE DEFECT COULD BE ATTRIBUTED TO MISUSE BY THE CONSUMER. BASED UPON AN ACCEPTABLE DOCUMENT REVIEW, RETAIN EVALUATION, AND NO ADVERSE TRENDS A ROOT CAUSE COULD NOT BE DETERMINED FOR THIS COMPLAINT. THE RETURNED SAMPLE WAS BROKEN HOWEVER THE FORCE REQUIRED FOR THIS TYPE OF BREAKAGE COULD NOT HAVE BEEN ATTAINED DURING NORMAL USE. THERE WAS NO CONSUMER INFORMATION REGARDING WHERE THE CONSUMER HELD THE BRUSH OR THE FORCE THEY USED WHILE USING THE BRUSH. ALTHOUGH THIS COMPLAINT WAS VERIFIED DUE TO THE RETURNED SAMPLE, THE DISPOSITION OF THIS COMPLAINT COULD BE NOT CONFIRMED AS IT COULD NOT BE ATTRIBUTED TO A MANUFACTURING DEFECT. BASED ON THE INFORMATION AVAILABLE, THIS DEVICE WAS USED AS INTENDED FOR TREATMENT. 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 CONSUMER (AGE AND GENDER UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING REACH ADVANCED DESIGN TOOTHBRUSH, FOR DENTAL CLEANING (ROUTE DENTAL, LOT NUMBER, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER THREE WEEKS OF USE, THE TOOTHBRUSH BROKE. THIS REPORT HAD NO ADVERSE EVENT AND THE ACTION TAKEN WITH THE DEVICE 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 CONSUMER (AGE AND GENDER UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING REACH ADVANCED DESIGN TOOTHBRUSH, FOR DENTAL CLEANING (ROUTE DENTAL, LOT NUMBER, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER THREE WEEKS OF USE, THE TOOTHBRUSH BROKE. THIS REPORT HAD NO ADVERSE EVENT AND THE ACTION TAKEN WITH THE DEVICE UNKNOWN. THIS REPORT WAS CONSIDERED A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013: NO LOT NUMBER REPORTED AND NO SAMPLE WAS RETURNED. 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. MONITORING OF COMPLAINT TRENDS WILL CONTINUE. THIS REPORT WAS CONSIDERED A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013: THE LOT NUMBER WAS UPDATED FROM UNSPECIFIED TO 0149SGS2. THIS REPORT REMAINS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2582 REACH BY DESIGN TOOTHBRUSH/ULTRACLEAN TOOTHBRUSH, MANUAL EFW SKILLMAN CONTRACT REULCTUS 0149SGS2

    Patients

    Seq Age Sex Outcome Treatment
    1