BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REACH J&J FLOSS CLEAN BURST SPEARMINT

    MDR report key: 3072079 · Received April 23, 2013

    Report

    Report Number
    8041101-2013-00023
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Report Date
    April 9, 2013
    Manufacturer
    JOHNSON & JOHNSON CONSUMER PRODUCTS
    Product Code
    JES
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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

    (B)(4). 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) 2013, FROM A CONSUMER (AGE AND GENDER UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING JOHNSON AND JOHNSON REACH CLEAN BURST ICY SPEARMINT DENTAL FLOSS FOR ORAL HYGIENE (ROUTE-DENTAL, LOT NUMBER 3462D, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, THE CONSUMER NOTICED THAT THE FLOSS WAS TANGLED AND TRIED TO TAKE IT OUT AND PLAY WITH THE SPOOL WHILE THE SPOOL KEPT GETTING JAMMED. THE CONSUMER TRIED TO PUT IT BACK IN AND THE BLADE THAT CUT THE FLOSS BROKE OFF AND GOT SEPARATED FROM THE DISPENSER. THE CONSUMER STATED THAT THERE WAS NOWHERE TO PULL THE FLOSS FROM TO START FOR THE NEXT FLOSS. THE CONSUMER TOOK THE TOP OFF COMPLETELY TO GET TO FLOSS. THE CONSUMER STATED THAT IT WAS NOT THE FIRST TIME IT HAPPENED. 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.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(4) 2013, FROM A CONSUMER (AGE AND GENDER UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING JOHNSON AND JOHNSON REACH CLEAN BURST ICY SPEARMINT DENTAL FLOSS FOR ORAL HYGIENE (ROUTE-DENTAL, LOT NUMBER 3462D, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, THE CONSUMER NOTICED THAT THE FLOSS WAS TANGLED AND TRIED TO TAKE IT OUT AND PLAY WITH THE SPOOL WHILE THE SPOOL KEPT GETTING JAMMED. THE CONSUMER TRIED TO PUT IT BACK IN AND THE BLADE THAT CUT THE FLOSS BROKE OFF AND GOT SEPARATED FROM THE DISPENSER. THE CONSUMER STATED THAT THERE WAS NOWHERE TO PULL THE FLOSS FROM TO START FOR THE NEXT FLOSS. THE CONSUMER TOOK THE TOP OFF COMPLETELY TO GET TO FLOSS. THE CONSUMER STATED THAT IT WAS NOT THE FIRST TIME IT HAPPENED. 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) 2013. A REVIEW OF THE COMPLAINT DATA REVEALED NO ADVERSE TRENDS AND NO TREND INVOLVING LOT NUMBER 3462D. COMPLAINT TRENDS WOULD CONTINUE TO BE MONITORED. A REVIEW OF THE DEVICE HISTORY RECORDS AND HISTORY OF CHANGES DID NOT INDICATE THAT THE DEVICE FAILED TO MEET SPECIFICATIONS. THE SAMPLE WAS RECEIVED OPENED AND WITH MISSING COMPONENTS (BOBBIN AND CORE). THE ONLY COMPONENTS RECEIVED WERE THE DISPENSER AND THE INSERT THAT PRECLUDED PERFORMING THE FIELD SAMPLE EVALUATION. BASED ON THE INFORMATION AVAILABLE, THIS DEVICE WAS USED AS INTENDED FOR TREATMENT. THE COMPLAINT CATEGORIES EVALUATED FOR THIS COMPLAINT SHOULD BE CLOSED WITH A DISPOSITION OF UNDETERMINED. THIS REPORT REMAINS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173849 REACH J&J FLOSS CLEAN BURST SPEARMINT DENTAL FLOSS JES JOHNSON & JOHNSON CONSUMER PRODUCTS REFCBSUS 3462D

    Patients

    Seq Age Sex Outcome Treatment
    1