BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REACH FLOSS UNSPECIFIED

    MDR report key: 6335067 · Received February 16, 2017

    Report

    Report Number
    8041101-2017-00005
    Event Type
    Malfunction
    Date Received
    February 16, 2017
    Report Date
    January 26, 2017
    Manufacturer
    JOHNSON & JOHNSON CONSUMER PRODUCTS
    Product Code
    JES
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS SUBMISSION IS 30-MAR-2017. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS SUBMISSION IS 16-FEB-2017. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON 26-JAN-2017 FROM A CONSUMER (AGE AND GENDER UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES OF AMERICA. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING REACH FLOSS UNSPECIFIED, DENTALLY FOR DENTAL HYGIENE (LOT NUMBER 3559D, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, THE CONSUMER NOTICED THAT THE SMALL PIECE ON THE RIGHT OF THE FLOSS WHERE THE FLOSS WAS SUPPOSED TO BE CUT WAS BROKEN. THE CONSUMER MENTIONED TO HAVE HELD THE FLOSS IN PLACE AND TRIED CUTTING IT. THIS REPORT HAD NO ADVERSE EVENT AND THE ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. THIS REPORT WAS CONSIDERED A REPORTABLE MALFUNCTION IN THE UNITED STATES OF AMERICA. ADDITIONAL INFORMATION WAS RECEIVED ON 13-MAR-2017, THE PRODUCT NAME WAS UPDATED FROM REACH FLOSS UNSPECIFIED TO JOHNSON AND JOHNSON FLOSS MINT WAXED AND THE PRODUCT CODE WAS UPDATED FROM REACH FLOSS UNSPECIFIED USA JRFLUNUS TO REACH J& J FLOSS WAXED MINT 100YD USA 381370092292 8137009229 USA. THE SAMPLES WERE RECEIVED ON 20-MAR-2017 AND WERE VISUALLY EXAMINED ON THE SAME DAY. LOT NUMBER WAS IDENTIFIED. PRODUCT MET SPECIFICATION AS DOCUMENTED IN THE RECORDS HOWEVER THE SAMPLE DOES NOT MEET SPECIFICATIONS AS IT WAS RECEIVED WITH INSERT BREAKAGE. RETAIN SAMPLE EVALUATION WAS NOT PERFORMED AS THE MENTIONED LOT NUMBER WAS DISCARDED IN ACCORDANCE WITH LOCAL PROCEDURES. A REVIEW OF COMPLAINT REVEALED NO UNFAVORABLE TRENDS FOR THE REPORTED LOT NUMBER. DEVICE HISTORY RECORDS WERE REVIEWED AND NO DEVIATIONS OR NON-CONFORMANCES WERE NOTED. BASED ON THE FIELD SAMPLE RESULTS, THERE WAS EVIDENCE THAT A DEVICE MALFUNCTION OCCURRED. BASED ON THE INFORMATION AVAILABLE, THE DEVICE WAS USED FOR INTENDED TREATMENT. THE ANALYSIS FOR THIS PRODUCT AND COMPLAINT CATEGORY WILL BE MANAGED THROUGH MONTHLY TRENDING PROCESS. THE CATEGORY EVALUATED FOR THIS COMPLAINT WAS CLOSED WITH A DISPOSITION OF CONFIRMED. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED PER ESTABLISHED PROCEDURE. THIS REPORT HAD NO ADVERSE EVENT. THIS REPORT REMAINS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES OF AMERICA.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON 26-JAN-2017 FROM A CONSUMER (AGE AND GENDER UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES OF AMERICA. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING REACH FLOSS UNSPECIFIED, DENTALLY FOR DENTAL HYGIENE (LOT NUMBER 3559D, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, THE CONSUMER NOTICED THAT THE SMALL PIECE ON THE RIGHT OF THE FLOSS WHERE THE FLOSS WAS SUPPOSED TO BE CUT WAS BROKEN. THE CONSUMER MENTIONED TO HAVE HELD THE FLOSS IN PLACE AND TRIED CUTTING IT. THIS REPORT HAD NO ADVERSE EVENT AND THE ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. THIS REPORT WAS CONSIDERED A REPORTABLE MALFUNCTION IN THE UNITED STATES OF AMERICA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117986 REACH FLOSS UNSPECIFIED DENTAL FLOSS JES JOHNSON & JOHNSON CONSUMER PRODUCTS 8137009229 3559D

    Patients

    Seq Age Sex Outcome Treatment
    1