BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOHNSON & JOHNSON FLOSS, MINT WAXED

    MDR report key: 3251402 · Received July 29, 2013

    Report

    Report Number
    8041101-2013-00035
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Report Date
    July 19, 2013
    Manufacturer
    JOHNSON & JOHNSON CONSUMER PRODUCTS
    Product Code
    JES
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    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) 2013, FROM A FEMALE CONSUMER (AGE UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING, JOHNSON AND JOHNSON FLOSS, MINT WAXED FOR DENTAL CLEANING (ROUTE-DENTAL, LOT NUMBER 2001D, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, THE CONSUMER NOTICED THAT THE PLASTIC MOLD WHICH HELD THE METAL TAB SPLIT AND METAL TAB CAME OFF AND THE FLOSS COULD NOT BE TORN OFF. THIS REPORT DOES NOT HAVE AN ADVERSE EVENT AND ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. THIS REPORT WAS CONSIDERED AS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON 03-SEP-2013 TWO SAMPLES OF SAME LOT NUMBER, 2001D WERE RECEIVED ON 07-AUG-2013 AND WERE VISUALLY EXAMINED. ONE SAMPLE WAS WITH BROKEN INSERT AND THE OTHER ONE WAS WITHOUT THE LIP THAT HOLDS THE LID OF THE DISPENSER. THE RETURNED SAMPLES DID NOT MEET SPECIFICATION FOR APPEARANCE. A REVIEW OF THE COMPLAINT DATA REVEALED NO UNFAVORABLE TRENDS AND NO TREND INVOLVING LOT NUMBER 2001D. COMPLAINT TRENDS WOULD CONTINUE TO BE MONITORED. EVALUATION OF RETAIN SAMPLE, BATCH RECORD REVIEW AND MANUFACTURING RELATED ISSUES DEMONSTRATED ADEQUATE CONTROLS AND DID NOT SHOW ANY GAPS IN THE PRODUCTION PROCESS THAT COULD POTENTIALLY AFFECT THE PRODUCT. AN INSPECTION TO THE FINAL PRODUCT WAS PERFORMED WITH A SAMPLING PLAN OF THE (B)(4) UNITS EVERY 4 HOURS IN ORDER TO ASSURE THE CORRECT DISPENSER ASSEMBLY, EASY FLOSS DISPENSING AND CORRECT ASSEMBLY OF THE DEVICE. AN INSPECTION TO THE ASSEMBLY OF THE CUTTER-INSERT WITH A SAMPLING PLAN OF THE (B)(4) UNITS EVERY 4 HOURS AND 30 UNITS EVERY 2 HOURS RESPECTIVELY FOCUSED ON BROKEN INSERT AND INCORRECT ASSEMBLY. DURING MANUFACTURING OF THE PRODUCT WAS NOT FOUND DEFECTIVE UNIT OF THE INSERT. DISPOSITION WAS CONFIRMED. 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)(4) 2013, FROM A FEMALE CONSUMER (AGE UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING, JOHNSON AND JOHNSON FLOSS, MINT WAXED FOR DENTAL CLEANING (ROUTE-DENTAL, LOT NUMBER 2001D, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, THE CONSUMER NOTICED THAT THE PLASTIC MOLD WHICH HELD THE METAL TAB SPLIT AND METAL TAB CAME OFF AND THE FLOSS COULD NOT BE TORN OFF. THIS REPORT DOES NOT HAVE AN ADVERSE EVENT AND 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
    354158 JOHNSON & JOHNSON FLOSS, MINT WAXED DENTAL FLOSS JES JOHNSON & JOHNSON CONSUMER PRODUCTS 8137009279 2001D

    Patients

    Seq Age Sex Outcome Treatment
    1