BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REACH ACCESS DAILY FLOSSER

    MDR report key: 3151280 · Received June 7, 2013

    Report

    Report Number
    8041101-2013-00028
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Report Date
    May 20, 2013
    Manufacturer
    JOHNSON & JOHNSON CONSUMER PRODUCTS
    Product Code
    JES
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS SUBMISSION IS 25-JUN-2013. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS SUBMISSION IS (B)(4)2 013. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON 20-MAY-2013 FROM A FEMALE CONSUMER (AGE UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. THE MEDICAL HISTORY INCLUDED ARTHRITIS. THE CONCOMITANT MEDICATIONS WERE NOT REPORTED. 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, THE CONSUMER NOTICED THAT THE FLOSSER HEAD DID NOT STAY IN THE FLOSSER. ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. THIS REPORT HAD NO ADVERSE EVENT. THE COMPANY CAUSALITY WAS ASSESSED AS POSSIBLE. THIS REPORT WAS CONSIDERED AS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. LOT NUMBER WAS NOT PROVIDED AND NO SAMPLE HAD BEEN RECEIVED. WITHOUT A LOT NUMBER, THE ANALYST COULD NEITHER PERFORM A BATCH RECORD REVIEW, THE RETAIN SAMPLE EVALUATION NOR LOT TREND ANALYSIS. A REVIEW OF THE COMPLAINT DATA REVEALED A POTENTIAL UPWARD TREND. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED. THIS COMPLAINT COULD NOT BE CONSIDERED CONFIRMED SINCE NO SAMPLE HAD BEEN RECEIVED. HISTORY OF CHANGES DEMONSTRATED ADEQUATE CONTROLS AND DID NOT SHOW ANY GAPS IN THE PRODUCTION PROCESS THAT COULD POTENTIALLY AFFECT THE PRODUCT. THE DEVICE WAS USED AS INTENDED FOR TREATMENT. DISPOSITION WAS UNDETERMINED. 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 FEMALE CONSUMER (AGE UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. THE MEDICAL HISTORY INCLUDED ARTHRITIS. THE CONCOMITANT MEDICATIONS WERE NOT REPORTED. 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, THE CONSUMER NOTICED THAT THE FLOSSER HEAD DID NOT STAY IN THE FLOSSER. ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. THIS REPORT HAD NO ADVERSE EVENT. THE COMPANY CAUSALITY WAS ASSESSED AS POSSIBLE. THIS REPORT WAS CONSIDERED AS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252631 REACH ACCESS DAILY FLOSSER DENTAL FLOSSER JES JOHNSON & JOHNSON CONSUMER PRODUCTS RADYFSUS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1