REACH TOTAL CARE PLUS WHITEN TOOTHBRUSH USA
Report
- Report Number
- 2214133-2012-00376
- Event Type
- Malfunction
- Date Received
- October 16, 2012
- Report Date
- October 3, 2012
- Manufacturer
- SKILLMAN CONTRACT
- Product Code
- EFW
- Removal / Correction Number
- NI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
(B)(4). THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.
THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.
(B)(4). THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.
THE DATE OF THIS SUBMISSION IS (B)(4) 2013. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.
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 TOTAL CARE PLUS WHITENING TOOTHBRUSH, FOR DENTAL CLEANING (ROUTE DENTAL, LOT NUMBER AND EXPIRATION DATE UNSPECIFIED). THE CONSUMER USED THE TOOTHBRUSH ABOUT TWICE AND ON LAST USE IT BROKE IN TWO. THIS REPORT HAD NO ADVERSE EVENT AND THE ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. THIS REPORT WAS CONSIDERED AS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2012. A SAMPLE WAS REQUESTED BUT WAS NOT RETURNED. A LOT NUMBER WAS NOT PROVIDED BY THE CONSUMER. A REVIEW OF THE TRENDING DATA BY PRODUCT FAMILY REACH TOTAL CARE PLUS WHITENING TOOTHBRUSH FOR BREAKS/FALLS APART WITH USE AND POTENTIAL MALFUNCTION REVEALED NO ADVERSE TRENDS; AN INCREASE WAS NOTED AND COULD BE ATTRIBUTED TO AN INCREASE IN SHIPMENT QUANTITY. THERE WERE NO RELATED MANUFACTURING OR FACILITY ISSUES FOUND WITHIN IN A (B)(4) REVIEW PERIOD PRIOR TO THE ALERT DATE OF THE COMPLAINT ((B)(4)). THE DESIGN/FORMULA/PACKAGING/LABELING CHANGES WAS REVIEWED FOR A (B)(4) REVIEW PERIOD PRIOR TO THE ALERT DATE OF THE COMPLAINT ((B)(4)). A BASIC HANDLE MATERIAL CHANGE WAS VALIDATED RELEASED ON (B)(4) 2012. BASED UPON AN ACCEPTABLE RELATED PRODUCT HISTORY REVIEW, MANUFACTURING OR FACILITY ISSUES REVIEW, DUE TO LACK OF A LOT NUMBER, SAMPLE AND NO ADVERSE TRENDS, THE COMPLAINT COULD NOT BE CONFIRMED AND A ROOT CAUSE COULD NOT BE DETERMINED FOR THIS COMPLAINT. COMPLAINT TRENDS WOULD CONTINUE TO BE MONITORED. THIS REPORT REMAINS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013. THE LOT NUMBER WAS UPDATED FROM UNSPECIFIED TO 19211SG S2. THIS REPORT REMAINS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013: PRODUCT WAS RETURNED AND VISUALLY INSPECTED. A MANUFACTURER REVIEW OF THE BATCH RECORDS FOR THE TOOTHBRUSH LOT 19211SG S2 DID NOT INDICATE ANY DEVIATIONS IN THE MANUFACTURE OF THIS LOT. THERE WERE NO MANUFACTURING OR FACILITY ATYPICAL EVENTS, DEVIATIONS OR NON-CONFORMANCES. THERE WERE 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. THE DEVICE HISTORY REVIEW AND VISUAL RETAIN EVALUATION FOR LOT 19211SG S2 BY MANUFACTURER WAS ACCEPTABLE. NO ADVERSE TRENDS HAVE BEEN NOTED WITH THIS PRODUCT OR LOT. ALTHOUGH THE RETURNED SAMPLE RECEIVED WAS BROKEN, MANUFACTURER STATES THE PRODUCT DEFECT WAS NOT DUE TO A MANUFACTURING OCCURRENCE AND THE BREAK OCCURRED DUE TO HIGH COMPRESSION FORCES AT THE THINNEST POINT ON THE HANDLE. THEY HAD VERIFIED THAT DURING THE VALIDATION OF THIS PRODUCT THE TOOTHBRUSH WAS SUBJECTED TO OVER BEND TESTING AND NO TOOTHBRUSHES BROKE. MANUFACTURER CONFIRMED THE RETURNED TOOTHBRUSH WAS MANUFACTURED ACCORDING TO SPECIFICATION. BASED ON THE INVESTIGATION PERFORMED, THE DISPOSITION OF THIS COMPLAINT IS UNDETERMINED. COMPLAINT TRENDS WOULD CONTINUE TO BE MONITORED. THIS REPORT REMAINS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.
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 TOTAL CARE PLUS WHITENING TOOTHBRUSH, FOR DENTAL CLEANING (ROUTE DENTAL, LOT NUMBER AND EXPIRATION DATE UNSPECIFIED). THE CONSUMER USED THE TOOTHBRUSH ABOUT TWICE AND ON LAST USE IT BROKE IN TWO. THIS REPORT HAD NO ADVERSE EVENT AND THE ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. THIS REPORT WAS CONSIDERED AS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2012. A SAMPLE WAS REQUESTED BUT WAS NOT RETURNED. A LOT NUMBER WAS NOT PROVIDED BY THE CONSUMER. A REVIEW OF THE TRENDING DATA BY PRODUCT FAMILY REACH TOTAL CARE PLUS WHITENING TOOTHBRUSH FOR BREAKS/FALLS APART WITH USE AND POTENTIAL MALFUNCTION REVEALED NO ADVERSE TRENDS; AN INCREASE WAS NOTED AND COULD BE ATTRIBUTED TO AN INCREASE IN SHIPMENT QUANTITY. THERE WERE NO RELATED MANUFACTURING OR FACILITY ISSUES FOUND WITHIN IN A TWO YEAR REVIEW PERIOD PRIOR TO THE ALERT DATE OF THE COMPLAINT ((B)(6) 2010 TO (B)(6) 2012). THE DESIGN/FORMULA/PACKAGING/LABELING CHANGES WAS REVIEWED FOR A TWO YEAR REVIEW PERIOD PRIOR TO THE ALERT DATE OF THE COMPLAINT ((B)(6) 2010 TO (B)(6) 2012). A BASIC HANDLE MATERIAL CHANGE WAS VALIDATED RELEASED ON (B)(6) 2012. BASED UPON AN ACCEPTABLE RELATED PRODUCT HISTORY REVIEW, MANUFACTURING OR FACILITY ISSUES REVIEW, DUE TO LACK OF A LOT NUMBER, SAMPLE AND NO ADVERSE TRENDS, THE COMPLAINT COULD NOT BE CONFIRMED AND A ROOT CAUSE COULD NOT BE DETERMINED FOR THIS COMPLAINT. COMPLAINT TRENDS WOULD CONTINUE TO BE MONITORED. THIS REPORT REMAINS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013. THE LOT NUMBER WAS UPDATED FROM UNSPECIFIED TO 19211SG S2. THIS REPORT REMAINS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.
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 TOTAL CARE PLUS WHITENING TOOTHBRUSH, FOR DENTAL CLEANING (ROUTE DENTAL, LOT NUMBER AND EXPIRATION DATE UNSPECIFIED). THE CONSUMER USED THE TOOTHBRUSH ABOUT TWICE AND ON LAST USE IT BROKE IN TWO. THIS REPORT HAD NO ADVERSE EVENT AND THE ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. THIS REPORT WAS CONSIDERED AS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2012. A SAMPLE WAS REQUESTED BUT WAS NOT RETURNED. A LOT NUMBER WAS NOT PROVIDED BY THE CONSUMER. A REVIEW OF THE TRENDING DATA BY PRODUCT FAMILY REACH TOTAL CARE PLUS WHITENING TOOTHBRUSH FOR BREAKS/FALLS APART WITH USE AND POTENTIAL MALFUNCTION REVEALED NO ADVERSE TRENDS; (B)(4). THERE WERE NO RELATED MANUFACTURING OR FACILITY ISSUES FOUND WITHIN IN A (B)(4) REVIEW PERIOD PRIOR TO THE ALERT DATE OF THE COMPLAINT ((B)(6) 2010 TO (B)(6) 2012). THE DESIGN/FORMULA/PACKAGING/LABELING CHANGES WAS REVIEWED FOR A (B)(4) REVIEW PERIOD PRIOR TO THE ALERT DATE OF THE COMPLAINT ((B)(6) 2010 TO (B)(6) 2012). A BASIC HANDLE MATERIAL CHANGE WAS VALIDATED RELEASED ON (B)(4) 2012. BASED UPON AN ACCEPTABLE RELATED PRODUCT HISTORY REVIEW, MANUFACTURING OR FACILITY ISSUES REVIEW, DUE TO LACK OF A LOT NUMBER, SAMPLE AND NO ADVERSE TRENDS, THE COMPLAINT COULD NOT BE CONFIRMED AND A ROOT CAUSE COULD NOT BE DETERMINED FOR THIS COMPLAINT. COMPLAINT TRENDS WOULD CONTINUE TO BE MONITORED. THIS REPORT REMAINS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.
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 TOTAL CARE PLUS WHITENING TOOTHBRUSH, FOR DENTAL CLEANING (ROUTE DENTAL, LOT NUMBER AND EXPIRATION DATE UNSPECIFIED). THE CONSUMER USED THE TOOTHBRUSH ABOUT TWICE AND ON LAST USE IT BROKE IN TWO. THIS REPORT HAD NO ADVERSE EVENT AND THE ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. THIS REPORT WAS CONSIDERED AS 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 USA | TOOTHBRUSH, MANUAL | EFW | SKILLMAN CONTRACT | RETCTHUS | 19211SG S2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |