BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REACH TOTAL CARE PLUS WHITENING DENTAL FLOSS

    MDR report key: 4220239 · Received November 3, 2014

    Report

    Report Number
    8041101-2014-00046
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Report Date
    October 21, 2014
    Manufacturer
    JOHNSON & JOHNSON CONSUMER PRODUCTS
    Product Code
    JES
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS SUBMISSION IS 03-NOV-2014. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS SUBMISSION IS 22-DEC-2014. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON 03-DEC-2014. THE RETURNED SAMPLE WAS RECEIVED ON 03-NOV-2014 WITH A PRINTED LOT NUMBER 2172D AND WAS VISUALLY EXAMINED. THE INSERT INSIDE THE DISPENSER WAS BROKEN ON THE EDGE WHERE THE CUTTER WAS ATTACHED. THE FIELD SAMPLE FAILED TO MEET SPECIFICATION. A REVIEW OF THE DATA REVEALED NO TREND FOR THE REPORTED LOT NUMBER. THE RETAINED SAMPLE WAS VISUALLY EVALUATED AND DID NOT PRESENT ANY DEFECT. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO ISSUE, DEFECT OR INVESTIGATION WAS CREATED RELATED TO INSERT BREAKAGE DEFECT. THE MANUFACTURING RELATED ISSUES WERE REVIEWED, AND T NO ISSUES WERE FOUND ASSOCIATED WITH INSERT BREAKAGE DEFECT FOR THE LOT NUMBER AND PRODUCT REPORTED . THE DEVICE WAS USED AS INTENDED FOR TREATMENT. BASED ON THE INVESTIGATION PERFORMED AND THE CONDITION OF THE RETURNED COMPLAINT SAMPLE THE DISPOSITION FOR THIS COMPLAINT WAS CONFIRMED. COMPLAINT TRENDS WILL 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 21-OCT-2014 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 DENTAL FLOSS (ROUTE-DENTAL, LOT NUMBER 2172D, EXPIRATION DATE AND FREQUENCY UNSPECIFIED) FOR GENERAL ORAL HEALTH. THE METAL CUTTER BROKE OFF WHILE THE CONSUMER WAS CUTTING THE FLOSS. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702113 REACH TOTAL CARE PLUS WHITENING DENTAL FLOSS DENTAL FLOSS JES JOHNSON & JOHNSON CONSUMER PRODUCTS 8137109128 2172D

    Patients

    Seq Age Sex Outcome Treatment
    1