BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REACH ACCESS DAILY FLOSSER

    MDR report key: 2921418 · Received January 18, 2013

    Report

    Report Number
    8041101-2013-00006
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Report Date
    January 9, 2013
    Manufacturer
    JOHNSON & JOHNSON CONSUMER PRODUCTS
    Product Code
    JES
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS SUBMISSION IS (B)(4) 2013. THIS IS AN INITIAL SUBMISSION FOR THE FIRST PRODUCT IN THIS CASE. THE MANUFACTURER REPORT NUMBER FOR THIS SUBMISSION IS 8041101-2013-00006. THE MANUFACTURER REPORT NUMBER FOR THE SECOND PRODUCT IN THIS CASE IS 8041101-2013-00005. 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 IS AN INITIAL SUBMISSION FOR THE FIRST PRODUCT IN THIS CASE. THE MANUFACTURER REPORT NUMBER FOR THIS SUBMISSION IS 8041101-2013-00006. THE MANUFACTURER REPORT NUMBER FOR THE SECOND PRODUCT IN THIS CASE IS 8041101-2013-00005. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS SUBMISSION IS 8-APR-2014. THIS IS FOLLOW UP SUBMISSION FOR THE SECOND PRODUCT IN THIS CASE. THE MANUFACTURER REPORT NUMBER FOR THIS SUBMISSION IS 8041101-2013-00006. THE MANUFACTURER REPORT NUMBER FOR THE FIRST PRODUCT IN THIS CASE IS 8041101-2013-00005. 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) 2013, FROM A CONSUMER (AGE AND GENDER UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING REACH ACCESS DAILY FLOSSER FOR DENTAL CLEANING (ROUTE: DENTAL, LOT NUMBER, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, THE CONSUMER STATED THAT WHILE USING THE DEVICE AND TRYING TO PUSH IT DOWN, IT WAS BREAKING/SNAPPING AND THEY SEEM TO BE THINNER. THE CONSUMER ALSO STATED THAT THE LAST COUPLE OF BATCHES WERE SNAPPING AND HAD TWO OF THE FLOSSERS WITH SIMILAR ISSUE. THIS 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 12-FEB-2013. AN EMPTY PACKAGE WAS RECEIVED WITHOUT THE PART OF THE BACK CARD WHERE THE LOT NUMBER WAS PLACED AND WITHOUT PRODUCT. A REVIEW OF THE COMPLAINT DATA REVEALED NO ADVERSE TRENDS. A REVIEW OF THE MANUFACTURING ISSUES (NON CONFORMANCES AND SPECIFICATION CHANGES) DOCUMENTATION DID NOT INDICATE REACH ACCESS DAILY FLOSSER FAILED TO MEET SPECIFICATIONS. THE HISTORY OF CHANGES FOR THE PRODUCT DEMONSTRATED ADEQUATE CONTROLS AND DID NOT SHOW ANY GAPS IN THE PRODUCTION PROCESS THAT COULD POTENTIALLY AFFECT THE PRODUCT. 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, THE CONSUMER STARTED USING REACH ACCESS DAILY FLOSSER FOR DENTAL CLEANING (ROUTE: DENTAL, LOT NUMBER, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, THE CONSUMER STATED THAT WHILE USING THE DEVICE AND TRYING TO PUSH IT DOWN, IT WAS BREAKING/SNAPPING AND THEY SEEM TO BE THINNER. THE CONSUMER ALSO STATED THAT THE LAST COUPLE OF BATCHES WERE SNAPPING AND HAD TWO OF THE FLOSSERS WITH SIMILAR ISSUE. THIS 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 09-JAN-2013, FROM A CONSUMER (AGE AND GENDER UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING REACH ACCESS DAILY FLOSSER FOR DENTAL CLEANING (ROUTE: DENTAL, LOT NUMBER, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, THE CONSUMER STATED THAT WHILE USING THE DEVICE AND TRYING TO PUSH IT DOWN, IT WAS BREAKING/SNAPPING AND THEY SEEM TO BE THINNER. THE CONSUMER ALSO STATED THAT THE LAST COUPLE OF BATCHES WERE SNAPPING AND HAD TWO OF THE FLOSSERS WITH SIMILAR ISSUE. THIS 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 12-FEB-2013. AN EMPTY PACKAGE WAS RECEIVED WITHOUT THE PART OF THE BACK CARD WHERE THE LOT NUMBER WAS PLACED AND WITHOUT PRODUCT. A REVIEW OF THE COMPLAINT DATA REVEALED NO ADVERSE TRENDS. A REVIEW OF THE MANUFACTURING ISSUES (NON CONFORMANCES AND SPECIFICATION CHANGES) DOCUMENTATION DID NOT INDICATE REACH ACCESS DAILY FLOSSER FAILED TO MEET SPECIFICATIONS. THE HISTORY OF CHANGES FOR THE PRODUCT DEMONSTRATED ADEQUATE CONTROLS AND DID NOT SHOW ANY GAPS IN THE PRODUCTION PROCESS THAT COULD POTENTIALLY AFFECT THE PRODUCT. COMPLAINT TRENDS WOULD CONTINUE TO BE MONITORED. THIS REPORT REMAINS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON 22-MAR-2014 A REVIEW OF THE MANUFACTURING ISSUES DID NOT INDICATE THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE HISTORY OF CHANGES FOR THE PRODUCT DEMONSTRATED ADEQUATE CONTROLS AND DID NOT SHOW ANY GAPS IN THE PRODUCTION PROCESS THAT COULD POTENTIALLY AFFECT THE PRODUCT. THE DISPOSITION REMAINED UNDETERMINED. COMPLAINT TRENDS WOULD WILL 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
    27573 REACH ACCESS DAILY FLOSSER DENTAL FLOSS JES JOHNSON & JOHNSON CONSUMER PRODUCTS 8137009658 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1