BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOHNSON & JOHNSON FLOSS, WAXED

    MDR report key: 4260802 · Received November 19, 2014

    Report

    Report Number
    8041101-2014-00048
    Event Type
    Malfunction
    Date Received
    November 19, 2014
    Report Date
    November 5, 2014
    Manufacturer
    JOHNSON & JOHNSON CONSUMER PRODUCTS
    Product Code
    JES
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS SUBMISSION IS 19-NOV-2014. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS SUBMISSION IS (B)(6) 2014. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2014. THE RETURNED SAMPLE RECEIVED ON (B)(6) 2014 WAS VISUALLY EXAMINED WITH A PRINTED LOT NUMBER 1413D. THE INSERT IS BROKEN ON THE EDGE WHERE THE CUTTER IS HOOKED. ACCORDING TO THE VISUAL EVALUATION THE FIELD SAMPLE DOES NOT MEET SPECIFICATION A REVIEW OF THE DATA ASSOCIATED WITH THE COMPLAINT CATEGORY INSERT BREAKAGE DEFECT FOR MEDIUM INSERT SIZE REVEALED NO TREND FOR THE LOT NUMBER. THE RETAIN SAMPLE WAS VISUALLY EVALUATED AND DOES NOT PRESENT ANY DEFECT. ALL PRODUCT COMPONENTS (CUTTER, INSERT, BOBBIN AND DISPENSER) PRESENT GOOD CONDITIONS. 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 THERE WAS NO ISSUE FOUND OR ASSOCIATED TO THE LOT NUMBER AND PRODUCT REPORTED FOR INSERT BREAKAGE DEFECT. THE DEVICE WAS USED AS INTENDED FOR TREATMENT. THE COMPLAINT INVESTIGATION WAS CLOSED WITH A DISPOSITION OF CONFIRMED SINCE THE FIELD SAMPLE WAS RECEIVED WITH BROKEN INSERT. 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 05-NOV-2014 FROM A CONSUMER (AGE AND GENDER UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING REACH JOHNSON AND JOHNSON FLOSS, WAXED (ROUTE- DENTAL, LOT NUMBER 1413D, FREQUENCY AND EXPIRATION DATE UNSPECIFIED) FOR ORAL HEALTH. WHILE USING THE FLOSS FOR THE FIRST TIME, THE CONSUMER PULLED THE STRING AND NOTICED THAT THE METAL CUTTER INCLUDING THE INNER PARTS OR PLASTIC ASSEMBLY CAME OFF THE CONTAINER ENTIRELY. 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
    751153 JOHNSON & JOHNSON FLOSS, WAXED DENTAL FLOSS JES JOHNSON & JOHNSON CONSUMER PRODUCTS 8137009213 1413D

    Patients

    Seq Age Sex Outcome Treatment
    1