BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LISTERINE ADVANCED DEFENSE SENSITIVE MOUTHWASH

    MDR report key: 17795836 · Received September 21, 2023

    Report

    Report Number
    2214133-2023-00030
    Event Type
    Injury
    Date Received
    September 21, 2023
    Date of Event
    February 5, 2022
    Report Date
    October 23, 2023
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    LBH
    PMA / PMN Number
    K143155
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. ADDITIONAL DATA: AGE - YEAR OF BIRTH (B)(6). A3 - UPDATED GENDER. B3 - UPDATED DATE OF EVENT. B5 - UPDATED REPORTER VERBATIM. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE FOLLOW-UP (01) MEDWATCH, A FOLLOW-UP MEDWATCH (02) WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    JOHNSON & AMP; 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 & AMP; 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 & AMP; JOHNSON CONSUMER, INC. OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AND ADMISSION THAT THE DEVICE, JOHNSON & AMP; JOHNSON CONSUMER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. D1, D2, D3, D4: THIS REPORT IS FOR ONE (1) LISTERINE ADVANCED DEFENSE SENSITIVE MOUTHWASH 500ML EU (B)(4), LOT NUMBER: N/I. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (LISTERINE SENSITIVITY ZERO ALCOHOL MOUTHRINSE FRSH MNT 500ML USA (B)(4). D4: UDI#: (B)(4). UPC#: 3574661122441. EXPIRATION DATE: NI. LOT#: NI. 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. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. H6: HEALTH EFFECT CLINICAL CODE: E040203 REFERS TO CONSUMER ALLEGED ABOUT & QUOT; TEETH STARTED TO GET BROWN SPOTS & QUOT; AFTER USING THIS PRODUCT. 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 · 0

    ADDITIONAL INFORMATION WAS REPORTED BY CONSUMER ON 10/23/2023. MALE CONSUMER REPORTED HIS YEAR OF BIRTH AS (B)(6). CONSUMER STATED THAT THE PRODUCT WAS USED FOR BETTER TEETH AND BAD BREATH TWO TIMES A DAY FOR ABOUT TWO YEARS. CONSUMER ALSO REPORTED THAT THE EVENT DATE WHEN SYMPTOMS OCCURRED WAS (B)(6), 2022 AND HE RECEIVED A DENTAL TREATMENT TWO TIMES TO REMOVE THE STAINING ON THE TEETH. CONSUMER REPORTED THAT SYMPTOMS END ON (B)(6) 2022.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED AN EVENT WITH LISTERINE ADVANCED DEFENSE SENSITIVE MOUTHWASH 500ML. CONSUMER ALLEGEDLY USED THE PRODUCT FOR AN ENTIRE YEAR AND HIS/HER TEETH STARTED TO GET BROWN SPOTS ON THEM. THE CONSUMER SOUGHT MEDICAL INTERVENTION FROM A DENTIST AND HAD THE BROWN SPOTS REMOVED FROM TEETH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509955 LISTERINE ADVANCED DEFENSE SENSITIVE MOUTHWASH VARNISH, CAVITY LBH JOHNSON & JOHNSON CONSUMER INC 3574661122441

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention