BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LISTERINE SENSITIVITY ZERO ALCOHOL MOUTHRINSE FRESH MINT

    MDR report key: 18581511 · Received January 25, 2024

    Report

    Report Number
    2214133-2024-00004
    Event Type
    Injury
    Date Received
    January 25, 2024
    Date of Event
    January 2, 2024
    Report Date
    January 26, 2024
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC.
    Product Code
    LBH
    PMA / PMN Number
    K143155
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 AND 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. A4, A5: WEIGHT, AND ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. D1, D2, D3, D4: THIS REPORT IS FOR (LISTERINE SENSITIVITY ZERO ALCOHOL MOUTHRINSE FRSH MNT 500ML USA 312547235976 1254723597USA 1254723597USA) LOT 00323CB D4: UDI #: (B)(4). UPC # 312547235976 EXPIRATION DATE: NI LOT #: 00323CB D10: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H4, H6: 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. H6: HEALTH EFFECT CLINICAL CODE: E040203 ALSO REFERS TO CONSUMER ALLEGED ¿CAVITY HAD TO BE REDONE.¿ E2330 ALSO REFERS TO CONSUMERS ALLEGED ¿PAIN IN GUMS, CHEEK AND TEETH.¿ E1705 ALSO REFERS TO CONSUMERS ALLEGED ¿GUMS ARE BURNING SENSATION.¿ E2326 ALSO REFERS TO CONSUMERS ALLEGED ¿EXTREME INFLAMMATION.¿ E2339 ALSO REFERS TO CONSUMERS ALLEGED ¿SORE THROUGHOUT MOUTH.¿ E0116 ALSO REFERS TO CONSUMERS ALLEGED ¿MIGRAINES.¿ THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED FOR LISTERINE SENSITIVITY ZERO ALCOHOL MOUTHRINSE. MEDWATCH 2214133-2024-00004 REPRESENTS THE 42 YEAR OLD MALE CONSUMER REPORTING HIS EVENT AND MEDWATCH 2214133-2024-00005 REPRESENTS THE UNCONFIRMED EVENT OF ¿OTHER PEOPLE HAD SIMILAR EXPERIENCES" THAT THE MALE CONSUMER ALLEGED. THESE EVENTS ARE PROVIDED BY THE SAME REPORTER. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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. UPDATED INFORMATION: D4: UDI #: (B)(4). UPC # 312547235976. EXPIRATION DATE: 11/30/2024. LOT #: 00323CB. H2, 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 DECEMBER 16, 2023. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE FOLLOW-UP #1 MEDWATCH, AN ADDITIONAL FOLLOW- UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    A 42-YEAR-OLD MALE CONSUMER REPORTED AN EVENT WITH LISTERINE SENSITIVITY ZERO ALCOHOL MOUTH RINSE. AFTER USING THE PRODUCT, THE CONSUMER HAD SHOOTING PAIN IN GUMS, CHEEK AND TEETH DESCRIBED AS THE WORST PAIN OF HIS LIFE FOR FOUR TO FIVE DAYS. CONSUMER STATED HE HAD EXTREME INFLAMMATION AND BURNING IN MOUTH AND GUMS. CONSUMER SOUGHT MEDICAL ATTENTION THROUGH HIS DENTIST AND HAD ¿CAVITY REDONE¿. CONSUMER REPORTED TAKING PAIN RELIEVERS AND PAIN RELIEVING GEL. CONSUMERS SYMPTOMS, IN ADDITION TO INFLAMMATION AND BURNING, WERE LACK OF SLEEP, SORES THROUGHOUT MOUTH, SHOOTING PAIN IN GUMS, CHEEK, TEETH, AND MIGRAINES FOR THE FIRST TIME IN HIS LIFE. CONSUMER HAS REPORTED HIS SYMPTOMS HAVE IMPROVED. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED FOR LISTERINE SENSITIVITY ZERO ALCOHOL MOUTHRINSE. MEDWATCH 2214133-2024-00004 REPRESENTS THE 42 YEAR OLD MALE CONSUMER REPORTING HIS EVENT AND MEDWATCH 2214133-2024-00005 REPRESENTS THE UNCONFIRMED EVENT OF ¿OTHER PEOPLE HAD SIMILAR EXPERIENCES" THAT THE MALE CONSUMER ALLEGED. THESE EVENTS ARE PROVIDED BY THE SAME REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1953213 LISTERINE SENSITIVITY ZERO ALCOHOL MOUTHRINSE FRESH MINT VARNISH, CAVITY LBH JOHNSON & JOHNSON CONSUMER INC. 312547235976 00323CB

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male Required Intervention