BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LISTERINE GENTLE GUM CARE FLOSS MINT

    MDR report key: 8185460 · Received December 20, 2018

    Report

    Report Number
    8041101-2018-00034
    Event Type
    Injury
    Date Received
    December 20, 2018
    Report Date
    November 30, 2018
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    JES
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT IDENTIFIER, AGE, SEX, WEIGHT, ETHNICITY AND RACE WAS NOT PROVIDED FOR REPORTING. THIS REPORT IS FOR UNKNOWN LISTERINE GENTLE GUM CARE FLOSS. UPC#, LOT# AND UDI # IS NOT AVAILABLE. 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. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 8041101-2018-00033. 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

    THE CONSUMER ALLEGED AFTER USING LISTERINE GENTLE GUM CARE FLOSS, HIS/HER GUMS REACTED VIOLENTLY AND GOT VERY SWOLLEN. THE CONSUMER WENT TO A PERIODONTIST, HAD A TISSUE BIOPSY AND ALMOST 5 MONTHS OF TREATMENTS. CONSUMER ALSO ALLEGED THE SYMPTOMS CAME BACK AFTER REINTRODUCED THE PRODUCT, THEREFORE THE DENTIST ALLEGED THAT THE CINNAMON IN THE DENTAL FLOSS CAUSED THE SWOLLEN GUM. THE CONSUMER HAS NOT USED THE FLOSS IN 3 WEEKS AND THE SWELLING IS IMPROVING. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 8041101-2018-00033. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1025401 LISTERINE GENTLE GUM CARE FLOSS MINT DENTAL FLOSS JES JOHNSON & JOHNSON CONSUMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention