BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REACH ACCESS DAILY FLOSSER

    MDR report key: 2914824 · Received January 15, 2013

    Report

    Report Number
    8041101-2013-00002
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Report Date
    January 7, 2013
    Manufacturer
    JOHNSON & JOHNSON CONSUMER PRODUCTS
    Product Code
    JES
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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)(6) 2013, FROM A MALE CONSUMER (AGE UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING REACH ACCESS DAILY FLOSSER, FOR DENTAL CLEANING, (ROUTE: DENTAL, FREQUENCY, LOT NUMBER AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, HE STATED THAT THE GREEN ONES HE BOUGHT KEPT BREAKING APART. 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: NO LOT NUMBER OR SAMPLE WAS PROVIDED. WITHOUT A LOT NUMBER, THE ANALYST COULD NEITHER PERFORM A MANUFACTURING AND PACKAGING BATCH RECORD REVIEW, AN INSPECTION OF THE RETAIN SAMPLE NOR LOT TREND ANALYSIS. A REVIEW OF THE DATA ASSOCIATED WITH THIS COMPLAINT CATEGORY REVEALED NO ADVERSE TRENDS. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED. 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 MALE CONSUMER (AGE UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING REACH ACCES DAILY FLOSSER, FOR DENTAL CLEANING, (ROUTE: DENTAL, FREQUENCY, LOT NUMBER AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, HE STATED THAT THE GREEN ONES HE BOUGHT KEPT BREAKING APART. 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
    22122 REACH ACCESS DAILY FLOSSER DENTAL FLOSSER JES JOHNSON & JOHNSON CONSUMER PRODUCTS RADYFSUS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1