BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REACH ACCESS DAILY FLOSSER

    MDR report key: 2923667 · Received January 22, 2013

    Report

    Report Number
    8041101-2013-00007
    Event Type
    Malfunction
    Date Received
    January 22, 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
    OH, 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

    THE DATE OF THIS SUBMISSION IS (B)(4) 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 ACCESS DAILY FLOSSER FOR DENTAL CLEANING (ROUTE-DENTAL, LOT NUMBER, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, THE CONSUMER STATED THAT WHILE USING THE FLOSSER, IT BROKE INTO TWO. 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 WAS RECEIVED ON (B)(4) 2013 NO LOT NUMBER OR SAMPLE WAS PROVIDED. WITHOUT A LOT NUMBER, A MANUFACTURING AND PACKAGING BATCH RECORD REVIEW, HISTORY RECORDS, AN INSPECTION OF THE RETAIN SAMPLE AND LOT TREND ANALYSIS COULD NOT BE PERFORMED. A REVIEW OF THE DATA ASSOCIATED WITH THE COMPLAINTS REVEALED NO ADVERSE TRENDS. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED. 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) 2013, FROM A CONSUMER (AGE AND GENDER 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, LOT NUMBER, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, THE CONSUMER STATED THAT WHILE USING THE FLOSSER, IT BROKE INTO TWO. 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
    30339 REACH ACCESS DAILY FLOSSER DENTAL FLOSSER JES JOHNSON & JOHNSON CONSUMER PRODUCTS RADYFSUS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1