BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LISTERINE ULTRACLEAN MINT FLOSS

    MDR report key: 10934323 · Received December 2, 2020

    Report

    Report Number
    8041101-2020-00019
    Event Type
    Malfunction
    Date Received
    December 2, 2020
    Report Date
    December 16, 2020
    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 OCTOBER 18, 2019. H3, H6: A MANUFACTURING INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE, IT WAS CONFIRMED THAT THE METAL CUTTER WAS COMPLETELY SEPARATED FROM THE INSERT ASSEMBLY. IT IS UNKNOWN HOW THE PRODUCT WAS BEING USED AT THE TIME. 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. THIS IS 1 OF 2 FOLLOW-UP MED-WATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 8041101-2020-00020. THE SAME CONSUMER IS REPRESENTED IN EACH MEDWATCH. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. UPC: (B)(4); LOT NUMBER: 29119D; EXPIRATION DATE: NA; UDI: (B)(4). DEVICE HAS BEEN RETURNED TO THE MANUFACTURER, AND IS UNDER EVALUATION/INVESTIGATION; A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN REQUESTED. UPON VISUAL EVALUATION OF THE ONE RETURNED DEVICE, IT WAS NOTED THAT THE METAL CUTTER WAS COMPLETELY SEPARATED FROM THE CONTAINER. PRODUCT WAS SHIPPED TO MANUFACTURING SITE FOR FURTHER EVALUATIONS. (B)(4). THIS IS 1 OF 2 MED-WATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 8041101-2020-00020. THE SAME CONSUMER IS REPRESENTED IN EACH MEDWATCH. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, AN ADDITIONAL FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    A MALE CONSUMER REPORTED AN EVENT WITH LISTERINE ULTRACLEAN MINT FLOSS. THE CONSUMER STATED THAT FOR THE SECOND TIME THE PACKAGING HAS FAILED. SPECIFICALLY, THE METAL CUTTER PIECE HAS COME DETACHED FROM THE FLOSS HOLDER, MAKING IT IMPOSSIBLE TO CUT THE FLOSS. IT WAS IMPOSSIBLE TO USE IN THE NORMAL FASHION. THIS EVENT OCCURRED DURING USE AND THERE WAS NO ADVERSE EVENT REPORTED. THIS IS 1 OF 2 MED-WATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH: 8041101-2020-00020. THE SAME CONSUMER IS REPRESENTED IN EACH MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1398370 LISTERINE ULTRACLEAN MINT FLOSS FLOSS, DENTAL JES JOHNSON & JOHNSON CONSUMER INC. 12547440133 29119D 12547440133

    Patients

    Seq Age Sex Outcome Treatment
    1