BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REACH LIST FLOSS CLEANBURST 50M

    MDR report key: 6197463 · Received December 21, 2016

    Report

    Report Number
    8041101-2016-00038
    Event Type
    Malfunction
    Date Received
    December 21, 2016
    Report Date
    December 1, 2016
    Manufacturer
    JOHNSON & JOHNSON CONSUMER PRODUCTS
    Product Code
    JES
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP FOREIGN REPORT IS BEING SUBMITTED 24-JAN-2017 FOR A DEVICE PRODUCT THAT IS CONSIDERED SAME/SIMILAR TO A US MARKETED DEVICE (LISTERINE COOL MINT FLOSS 55YD).THIS CLOSES OUT THE REPORT UNLESS ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS FOREIGN REPORT IS BEING SUBMITTED AS A DEVICE PRODUCT THAT IS CONSIDERED SAME/SIMILAR TO A US MARKETED DEVICE (LISTERINE COOL MINT FLOSS 55YD). THIS CLOSES OUT THE REPORT UNLESS ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS FOREIGN REPORT IS BEING SUBMITTED ON 16-MAR-2017 FOR A DEVICE PRODUCT THAT IS CONSIDERED SAME/SIMILAR TO A US MARKETED DEVICE (LISTERINE COOL MINT FLOSS 55 YD ). THIS CLOSES OUT THE REPORT UNLESS ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2016 FROM A CONSUMER (AGE AND GENDER UNSPECIFIED) REPORTING ON SELF FROM (B)(6). ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING REACH LIST FLOSS CLEANBURST 50M, FOR DENTAL HYGIENE BY USING IT COUPLE OF TIMES (ROUTE: DENTAL, LOT NUMBER 0085D, EXPIRATION DATE AND FREQUENCY UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, THE CONSUMER NOTICED THAT CUTTER SNAPPED OFF WHEN THE DEVICE WAS USED. THIS REPORT HAD NO ADVERSE EVENT AND THE ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. TILL 05-DEC-2016, FIELD SAMPLE WAS NOT RECEIVED. THE CONFIRMATION OF THIS COMPLAINT WAS INCONCLUSIVE. THIS REPORT WAS CONSIDERED A REPORTABLE MALFUNCTION IN THE UNITED STATES OF AMERICA. ADDITIONAL INFORMATION WAS RECEIVED ON 14-JAN-2017. A REVIEW OF THE DATA REVEALED NO UNFAVORABLE TRENDS FOR THE REPORTED LOT NUMBER. THE ANALYSIS OF PRODUCT AND COMPLAINT CATEGORY WILL BE MANAGED THROUGH A MONTHLY TRENDING PROCESS. AS PER THE RECORDS AND RETAIN SAMPLE REVIEW, THE PRODUCT MET SPECIFICATION. BASED ON THE INVESTIGATION RESULTS, THERE WAS NO EVIDENCE THAT A DEVICE MALFUNCTION OCCURRED. BASED ON THE INFORMATION AVAILABLE, THIS DEVICE WAS USED FOR INTENDED TREATMENT. THE COMPLAINT INVESTIGATION WAS CLOSED WITH A DISPOSITION OF UNDETERMINED. THIS REPORT REMAINS AS A REPORTABLE MALFUNCTION IN THE UNITED STATES OF AMERICA.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2016 FROM A CONSUMER (AGE AND GENDER UNSPECIFIED) REPORTING ON SELF FROM (B)(6) . ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING REACH LIST FLOSS CLEANBURST 50M, FOR DENTAL HYGIENE BY USING IT COUPLE OF TIMES (ROUTE: DENTAL, LOT NUMBER 0085D, EXPIRATION DATE AND FREQUENCY UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, THE CONSUMER NOTICED THAT CUTTER SNAPPED OFF WHEN THE DEVICE WAS USED. THIS REPORT HAD NO ADVERSE EVENT AND THE ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. TILL (B)(6) 2016, FIELD SAMPLE WAS NOT RECEIVED. THE CONFIRMATION OF THIS COMPLAINT WAS INCONCLUSIVE. THIS REPORT WAS CONSIDERED A REPORTABLE MALFUNCTION IN THE UNITED STATES OF AMERICA.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON 01-DEC-2016 FROM A CONSUMER (AGE AND GENDER UNSPECIFIED) REPORTING ON SELF FROM (B)(6). ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING REACH LIST FLOSS CLEANBURST 50 M, FOR DENTAL HYGIENE BY USING IT COUPLE OF TIMES (ROUTE: DENTAL, LOT NUMBER 0085D, EXPIRATION DATE AND FREQUENCY UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, THE CONSUMER NOTICED THAT CUTTER SNAPPED OFF WHEN THE DEVICE WAS USED. THIS REPORT HAD NO ADVERSE EVENT AND THE ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. TILL 05-DEC-2016, FIELD SAMPLE WAS NOT RECEIVED. THE CONFIRMATION OF THIS COMPLAINT WAS INCONCLUSIVE. THIS REPORT WAS CONSIDERED A REPORTABLE MALFUNCTION IN THE UNITED STATES OF AMERICA. ADDITIONAL INFORMATION WAS RECEIVED ON 14-JAN-2017. A REVIEW OF THE DATA REVEALED NO UNFAVORABLE TRENDS FOR THE REPORTED LOT NUMBER. THE ANALYSIS OF PRODUCT AND COMPLAINT CATEGORY WILL BE MANAGED THROUGH A MONTHLY TRENDING PROCESS. AS PER THE RECORDS AND RETAIN SAMPLE REVIEW, THE PRODUCT MET SPECIFICATION. BASED ON THE INVESTIGATION RESULTS, THERE WAS NO EVIDENCE THAT A DEVICE MALFUNCTION OCCURRED. BASED ON THE INFORMATION AVAILABLE, THIS DEVICE WAS USED FOR INTENDED TREATMENT. THE COMPLAINT INVESTIGATION WAS CLOSED WITH A DISPOSITION OF UNDETERMINED. THIS REPORT REMAINS AS A REPORTABLE MALFUNCTION IN THE UNITED STATES OF AMERICA. ADDITIONAL INFORMATION RECEIVED ON 03-MAR-2017. ON 16-FEB-2017, ONE FIELD SAMPLE WAS RECEIVED AND EVALUATED. BASED ON THE QUALITY INVESTIGATIONS, IT WAS FOUND THAT THE FIELD SAMPLE DID NOT MEET SPECIFICATIONS FOR APPEARANCE BECAUSE THE SAMPLE WAS RECEIVED WITH INSERT BREAKAGE. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DEVIATIONS OR NON-CONFORMANCES WERE NOTED. THE VISUAL INSPECTION WAS PERFORMED ON THE RETAIN SAMPLES AND ALL RESULTS MET SPECIFICATION. THE DEVICE MET SPECIFICATION AS DOCUMENTED IN THE RECORDS AND RETAIN SAMPLE REVIEWED. HOWEVER, THE FIELD SAMPLE DID NOT MEET SPECIFICATION WHICH HAD BEEN VERIFIED. IN ADDITION, BASED ON THE FIELD SAMPLE RESULTS, THERE WAS EVIDENCE THAT A DEVICE MALFUNCTION OCCURRED. HOWEVER, A REVIEW OF THE DATA ASSOCIATED WITH THE DEFECT PLASTIC INSERT ASSEMBLY WITH CUTTER PORTIONS THAT BROKE DURING USAGE FOR MEDIUM SIZE WAS PERFORMED AND NO UNFAVORABLE TRENDS WERE IDENTIFIED. THE COMPLAINT INVESTIGATION WAS CLOSED WITH A DISPOSITION OF CONFIRMED. THIS REPORT REMAINS AS A REPORTABLE MALFUNCTION IN THE UNITED STATES OF AMERICA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845823 REACH LIST FLOSS CLEANBURST 50M DENTAL FLOSS JES JOHNSON & JOHNSON CONSUMER PRODUCTS 0041914031 0085D

    Patients

    Seq Age Sex Outcome Treatment
    1