BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REACH TOTAL CARE PLUS WHITENING DENTAL FLOSS

    MDR report key: 3253580 · Received July 30, 2013

    Report

    Report Number
    8041101-2013-00036
    Event Type
    Malfunction
    Date Received
    July 30, 2013
    Report Date
    July 24, 2013
    Manufacturer
    JOHNSON & JOHNSON CONSUMER PRODUCTS
    Product Code
    JES
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS SUBMISSION IS (B)(4) 2013. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS SUBMISSION IS (B)(6) 2013. 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 REACH TOTAL CARE PLUS WHITENING DENTAL FLOSS, EVERY NIGHT TO CLEAN THE TEETH (ROUTE DENTAL, LOT NUMBER 2442D AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, THE CONSUMER WAS NOT ABLE TO TAKE THE FLOSS OUT OFF THE CONTAINER; HENCE CONSUMER PULLED IT HARD AS A RESULT OF WHICH THE ENTIRE METAL CUTTER BROKE AND GOT SEPARATED FROM THE CONTAINER. THE CONSUMER HAD TO USE SCISSORS TO CUT THE FLOSS. 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)(6) 2013 FROM A CONSUMER (AGE AND GENDER UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING REACH TOTAL CARE PLUS WHITENING DENTAL FLOSS, EVERY NIGHT TO CLEAN THE TEETH (ROUTE DENTAL, LOT NUMBER 2442D AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, THE CONSUMER WAS NOT ABLE TO TAKE THE FLOSS OUT OF THE CONTAINER; HENCE CONSUMER PULLED IT HARD AS A RESULT OF WHICH THE ENTIRE METAL CUTTER BROKE AND GOT SEPARATED FROM THE CONTAINER. THE CONSUMER HAD TO USE SCISSORS TO CUT THE FLOSS. 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 03-SEP-2013. A REVIEW OF THE DATA REVEALED NO UNFAVORABLE TRENDS AND NO TREND INVOLVING LOT NUMBER 2442D. A REVIEW OF THE RETAIN SAMPLE, BATCH RECORD REVIEW AND MANUFACTURING ISSUES DID NOT INDICATE REACH TOTAL CARE PLUS WHITENING DENTAL FLOSS FAILED TO MEET SPECIFICATIONS. THE RETURNED SAMPLE WAS RECEIVED FOR EVALUATION ON (B)(4) 2013. DUE TO THE CONDITION OF THE SAMPLE, THE ANALYST COULD NOT EVALUATE THE PARTICULAR ALLEGED DEFECT. THE COMPLAINT WAS CLOSED WITH A DISPOSITION OF UNDETERMINED. BASED ON THE INFORMATION AVAILABLE THE DEVICE WAS USED AS INTENDED FOR TREATMENT. COMPLAINT TRENDS WOULD CONTINUE TO BE MONITORED. THIS CASE REMAINS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355078 REACH TOTAL CARE PLUS WHITENING DENTAL FLOSS DENTAL FLOSS JES JOHNSON & JOHNSON CONSUMER PRODUCTS 8137109128 2442D

    Patients

    Seq Age Sex Outcome Treatment
    1