BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REACH ACCESS DAILY FLOSSER

    MDR report key: 3051865 · Received April 11, 2013

    Report

    Report Number
    8041101-2013-00021
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Report Date
    January 11, 2013
    Manufacturer
    JOHNSON & JOHNSON CONSUMER PRODUCTS
    Product Code
    JES
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR THE SECOND FLOSS OF THE THREE FLOSSES. THIS REPORT HAS MFR # 8041101-2013-00021 AND THE OTHER TWO REPORTS HAVE MFR # 8041101-2013-00004 AND 8041101-2013-00022, RESPECTIVELY. 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

    THIS REPORT IS FOR THE SECOND FLOSS OF THE THREE FLOSSES. THIS REPORT HAS MFR # 8041101-2013-00021 AND THE OTHER TWO REPORTS HAVE MFR # 8041101-2013-00004 AND 8041101-2013-00022 RESPECTIVELY. (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 FEMALE 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, LOT NUMBER 3531D, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, SHE NOTICED THAT THE DEVICE BROKE APART AND DID NOT LAST FOR HER TO USE IN THE ENTIRE MOUTH. SHE ALSO STATED THAT THE PREVIOUS THREE BOXES OF THE DEVICE SHE PURCHASED DID NOT LAST. 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 FEMALE 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, LOT NUMBER 3531D, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, SHE NOTICED THAT THE DEVICE BROKE APART AND DID NOT LAST FOR HER TO USE IN THE ENTIRE MOUTH. SHE ALSO STATED THAT THE PREVIOUS THREE BOXES OF THE DEVICE SHE PURCHASED DID NOT LAST. 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 FOUND NO ADVERSE TREND AND NO TREND INVOLVING THE REPORTED LOT NUMBER 3531D. INCREASED NUMBER OF COMPLAINTS WERE RECEIVED. THE ANALYSIS OF THE PRODUCT, CATEGORY, LOT TREND, THE REVIEW OF THE MANUFACTURING ISSUES (NON CONFORMANCES AND SPECIFICATION CHANGES), DEVICE HISTORY RECORDS AND RETAIN SAMPLE EVALUATION DID NOT INDICATE REACH ACCESS DAILY FLOSSER LOT 3531D FAILED TO MEET SPECIFICATIONS. SAMPLE WAS RECEIVED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONSIDERED CONFIRMED SINCE PRODUCT PACKAGING WAS RECEIVED EMPTY. HOWEVER, HISTORY OF CHANGES DEMONSTRATED ADEQUATE CONTROLS AND DID NOT SHOW ANY GAPS IN THE PRODUCTION PROCESS THAT COULD POTENTIALLY AFFECT THE PRODUCT. DISPOSITION WAS UNDETERMINED. COMPLAINT TRENDS WOULD CONTINUE TO BE MONITORED. THIS REPORT REMAINS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156570 REACH ACCESS DAILY FLOSSER DENTAL FLOSS JES JOHNSON & JOHNSON CONSUMER PRODUCTS 8137009658 3531D

    Patients

    Seq Age Sex Outcome Treatment
    1