BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LISTERINE ULTRACLEAN ACCESS FLOSSER REPLACE HEADS MINT

    MDR report key: 10011765 · Received April 29, 2020

    Report

    Report Number
    8041101-2020-00012
    Event Type
    Malfunction
    Date Received
    April 29, 2020
    Report Date
    May 17, 2020
    Manufacturer
    JOHNSON & JOHNSON CONSUMER PRODUCTS DR PARQUE INDU
    Product Code
    JES
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 10, 2019. THIS IS 4 OF 4 MED-WATCHES BEING SUBMITTED AS FOUR DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCHES 8041101-2020-00009; 8041101-2020-00010; 8041101-2020-00011; 8041101-2020-00012. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE FOLLOW-UP #1 MEDWATCH, AN ADDITIONAL FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT AGE, WEIGHT AND ETHNICITY WERE NOT PROVIDED FOR REPORTING. UDI: (B)(4). UPC: (B)(4). LOT NUMBER: 28419D. 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. THIS IS 4 OF 4 MED-WATCHES BEING SUBMITTED AS FOUR DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCHES 8041101-2020-00009; 8041101-2020-00010; 8041101-2020-00011. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH. 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

    CONSUMER REPORTED FOUR LISTERINE ULTRACLEAN ACCESS FLOSSER REPLACE HEADS SEPARATED FROM THE HANDLE WHEN USING IT INSIDE THE MOUTH. THERE WERE NO ADVERSE EVENT REPORTED WITH THIS EVENT. THIS IS 4 OF 4 MED-WATCHES BEING SUBMITTED AS FOUR DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCHES 8041101-2020-00009; 8041101-2020-00010; 8041101-2020-00011. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472345 LISTERINE ULTRACLEAN ACCESS FLOSSER REPLACE HEADS MINT FLOSS, DENTAL JES JOHNSON & JOHNSON CONSUMER PRODUCTS DR PARQUE INDU 12547440195 28419D

    Patients

    Seq Age Sex Outcome Treatment
    1