BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REACH J&J FLOSS GENTLEGUM CARE FLUORIDE USA

    MDR report key: 2791983 · Received October 16, 2012

    Report

    Report Number
    8041101-2012-00255
    Event Type
    Malfunction
    Date Received
    October 16, 2012
    Report Date
    October 9, 2012
    Manufacturer
    JOHNSON & JOHNSON CONSUMER PRODUCTS
    Product Code
    JES
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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

    THE DATE OF THIS SUBMISSION IS (B)(4) 2012. 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) 2012, 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 GENTLE GUM CARE, FLUORIDE, FOR DENTAL CLEANING (ROUTE DENTAL, LOT NUMBER 3421D, FREQUENCY, AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, THE CONSUMER NOTICED THAT THE CUTTING PIECE OF THE FLOSS BROKE OFF AND WAS UNABLE TO USE THE FLOSS. THE CONSUMER HAD USED SCISSORS TO CUT THE FLOSS. THE CONSUMER USED THE FLOSS IN THE PAST WITHOUT ANY PROBLEM. 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 RECEIVED ON (B)(4) 2012: A REVIEW OF THE DATA ASSOCIATED WITH THIS COMPLAINT CATEGORY REVEALED NO ADVERSE TRENDS AND NO TREND INVOLVING LOT NUMBER 3421D. COMPLAINT COULD NOT BE CONSIDERED CONFIRMED SINCE CUSTOMER UNIT WAS NOT RECEIVED. DOCUMENTATION AND HISTORY OF CHANGES DEMONSTRATE ADEQUATE CONTROLS DID NOT SHOW ANY GAPS IN THE PRODUCTION PROCESS THAT COULD POTENTIALLY AFFECT THE PRODUCT. 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 (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 JOHNSON AND JOHNSON FLOSS GENTLE GUM CARE, FLUORIDE, FOR DENTAL CLEANING (ROUTE DENTAL, LOT NUMBER 3421D, FREQUENCY, AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, THE CONSUMER NOTICED THAT THE CUTTING PIECE OF THE FLOSS BROKE OFF AND WAS UNABLE TO USE THE FLOSS. THE CONSUMER HAD USED SCISSORS TO CUT THE FLOSS. THE CONSUMER USED THE FLOSS IN THE PAST WITHOUT ANY PROBLEM. 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 J&J FLOSS GENTLEGUM CARE FLUORIDE USA DENTAL FLOSS JES JOHNSON & JOHNSON CONSUMER PRODUCTS REFGGFUS 3421D

    Patients

    Seq Age Sex Outcome Treatment
    1