BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LISTERINE GENTLE GUM CARE FLOSS MINT

    MDR report key: 8569594 · Received May 1, 2019

    Report

    Report Number
    8041101-2019-00040
    Event Type
    Malfunction
    Date Received
    May 1, 2019
    Report Date
    May 19, 2019
    Manufacturer
    JOHNSON & JOHNSON CONSUMER PRODUCTS INC
    Product Code
    JES
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. 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 JUNE 8, 2018. 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. (B)(4). EXPIRATION DATE= NA, LOT NUMBER = 1598D. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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 FEMALE CONSUMER REPORTED THAT THE LISTERINE GENTLE GUM CARE FLOSS MINT METAL CUTTER SEPARATED FROM THE PLASTIC INSERT. THE CONSUMER STATED THAT WHEN TRYING TO USE THE FLOSS, THE SPOOL CAME OUT OF THE CONTAINER AND THE METAL CUTTER BROKE OFF COMPLETELY FROM THE PLASTIC INSERT. THERE WERE NO ADVERSE EVENTS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362618 LISTERINE GENTLE GUM CARE FLOSS MINT DENTAL FLOSS JES JOHNSON & JOHNSON CONSUMER PRODUCTS INC 12547440157 1598D

    Patients

    Seq Age Sex Outcome Treatment
    1