BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LISTERINE ULTRACLEAN MINT FLOSS

    MDR report key: 9489088 · Received December 18, 2019

    Report

    Report Number
    8041101-2019-00060
    Event Type
    Malfunction
    Date Received
    December 18, 2019
    Report Date
    December 30, 2019
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    JES
    UDI-DI
    12547440133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    JOHNSON & JOHNSON CONSUMER, INC. IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH JOHNSON & JOHNSON CONSUMER, INC. HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, JOHNSON & JOHNSON CONSUMER, INC. OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, JOHNSON & JOHNSON CONSUMER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. H4, H6: DEVICE HISTORY RECORDS REVIEW WAS COMPLETED. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION AND PRODUCT WAS MANUFACTURED PER SPECIFICATION. THE PRODUCT WAS MANUFACTURED ON NOVEMBER 7,2017. H3, H6: A MANUFACTURING INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE, THE PRODUCT RECEIVED AS FIELD SAMPLE DOES NOT MEET SPECIFICATIONS DUE TO THE SAMPLE WAS RECEIVED WITH INSERT BREAKAGE. THE CUTTER AND THE PLASTIC PART THAT WAS SEPARATED WAS NOT RECEIVED. AT THIS TIME, NO CONCLUSION IS ABLE TO BE DRAWN ABOUT THE CAUSE OF THE METAL CUTTER SEPARATION AS NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE USE OF THE DEVICE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THIS FOLLOW-UP MEDWATCH, AN ADDITIONAL FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. UDI: (B)(4), UPC = (01)12547440133, EXPIRATION DATE= NA, LOT NUMBER = 3137D. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND IS UNDER EVALUATION/INVESTIGATION AND A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN REQUESTED. UPON VISUAL EVALUATION OF THE RETURNED DEVICE, IT WAS NOTED THAT THE SAMPLE WAS RECEIVED WITH INSERT BREAKAGE WITH THE CUTTER SEPARATED FROM INSERT ASSEMBLY AND CUTTER WAS NOT RETURNED. PRODUCT WAS SHIPPED TO MANUFACTURING SITE FOR FURTHER EVALUATIONS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    A CONSUMER REPORTED AN EVENT WITH LISTERINE ULTRACLEAN MINT FLOSS 30YD USA. THE CONSUMER REPORTED THAT THE METAL CUTTER AND PLASTIC INSERT FELL OFF ABOUT HALF WAY THROUGH WITH USE OF THE PRODUCT. THIS IS ALL KNOWN INFORMATION AT THIS TIME ABOUT THIS COMPLAINT. THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1282713 LISTERINE ULTRACLEAN MINT FLOSS DENTAL FLOSS JES JOHNSON & JOHNSON CONSUMER INC 12547440133 3137D 12547440133

    Patients

    Seq Age Sex Outcome Treatment
    1