BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LISTERINE GENTLE GUM CARE FLOSS MINT

    MDR report key: 8554607 · Received April 26, 2019

    Report

    Report Number
    8041101-2019-00038
    Event Type
    Malfunction
    Date Received
    April 26, 2019
    Report Date
    May 8, 2019
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    JES
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 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. 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). LOT NUMBER: (10)1158D, EXPIRATION DATE: NA. PRODUCT WAS RETURNED FOR INVESTIGATION FOR A BROKEN CUTTER. UPON VISUAL EVALUATION OF THE RETURNED DEVICE, IT WAS NOTED THAT THE METAL CUTTER WAS COMPLETELY SEPARATED FROM THE INSERT ASSEMBLY. IT IS UNKNOWN HOW THE PRODUCT WAS BEING USED AT THE TIME. ADDITIONAL EVALUATION IS PENDING FROM MANUFACTURING SITE. 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 APRIL 25, 2018. 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 MALE CONSUMER REPORTED THAT WHILE USING LISTERINE GENTLE GUM CARE FLOSS MINT 50YD THE METAL CUTTER WAS FALLING OFF THE PLASTIC INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347578 LISTERINE GENTLE GUM CARE FLOSS MINT DENTAL FLOSS JES JOHNSON & JOHNSON CONSUMER INC 12547440157 1158D

    Patients

    Seq Age Sex Outcome Treatment
    1