BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REACH J&J FLOSS WAXED MINT USA

    MDR report key: 2746414 · Received September 17, 2012

    Report

    Report Number
    8041101-2012-00251
    Event Type
    Malfunction
    Date Received
    September 17, 2012
    Report Date
    September 5, 2012
    Manufacturer
    JOHNSON & JOHNSON CONSUMER PRODUCTS
    Product Code
    JES
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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)(4) 2012, FROM A MALE CONSUMER (AGE UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING REACH JOHNSON AND JOHNSON FLOSS, MINT WAXED, FOR DENTAL CLEANING (ROUTE-DENTAL, LOT NUMBER 0102D, EXPIRATION DATE AND FREQUENCY UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, HE NOTICED THAT THE CUTTING PORTION OF THE FLOSS BROKE OFF. HE STATED THAT, HE HAD USED THE FLOSS IN THE PAST SINCE YEARS WITHOUT ANY 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 (B)(4) 2012. A REVIEW OF DATA REVEALED NO ADVERSE TRENDS AND NO TREND INVOLVING LOT NUMBER 0102D. A REVIEW OF THE HISTORY OF CHANGES, RETAIN SAMPLE EVALUATION AND DEVICE HISTORY RECORDS DID NOT INDICATE REACH JOHNSON AND JOHNSON FLOSS, MINT WAXED FAILED TO MEET SPECIFICATIONS. FIELD SAMPLE WAS EVALUATED AND PRESENTED THE INSERT BROKEN WHERE IT HOLDS THE CUTTER. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED. THE INVESTIGATION WAS CLOSED WITH A DISPOSITION OF CONFIRMED. 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 MALE CONSUMER (AGE UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING REACH JOHNSON AND JOHNSON FLOSS, MINT WAXED, FOR DENTAL CLEANING (ROUTE-DENTAL, LOT NUMBER 0102D, EXPIRATION DATE AND FREQUENCY UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, HE NOTICED THAT THE CUTTING PORTION OF THE FLOSS BROKE OFF. HE STATED THAT, HE HAD USED THE FLOSS IN THE PAST SINCE YEARS WITHOUT ANY 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REACH J&J FLOSS WAXED MINT USA DENTAL FLOSS JES JOHNSON & JOHNSON CONSUMER PRODUCTS REFWMTUS 0102D

    Patients

    Seq Age Sex Outcome Treatment
    1