BEUDAMED
    FDA Adverse Event Summary report: N

    GUM(R) PERIOSHIELD ORAL HEALTH RINSE 300 ML (10 FL. OZ.) BLUE BOTTLES

    MDR report key: 12016740 · Received June 16, 2021

    Report

    Report Number
    MW5101956
    Date Received
    June 16, 2021
    Date of Event
    June 1, 2021
    Report Date
    June 9, 2021
    Product Code
    NTO
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I RECEIVED A LETTER IN THE MAIL DATED (B)(6) 2021 REGARDING SUNSTAR AMERICAS INC (SAI), GUM PERIOSHIELD ORAL HEALTH RINSE. I WAS NOT ABLE TO FIND THAT RECALL LETTER IN YOUR INVENTORY BUT DID FIND THAT ANOTHER PRODUCT FROM SUNSTAR WITH THE SAME MICROORGANISM (BURKHOLDERIA CEPACIA OR CONTAMINANTS) WAS PREVIOUSLY RECALLED, SO I AM SUBMITTING MY RESPONSE FORM HERE. I PURCHASED A TOTAL OF 10 BOTTLES OF THE PRODUCT IN QUESTION, WITH 6 REMAINING UNUSED AND ONE PARTIALLY USED. THE PRODUCT IS IN A BLUE BOTTLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902813 GUM(R) PERIOSHIELD ORAL HEALTH RINSE 300 ML (10 FL. OZ.) BLUE BOTTLES RINSE, ORAL, ANTIBACTERIAL (BY PHYSICAL MEANS) NTO 01A
    902814 GUM(R) PERIOSHIELD ORAL HEALTH RINSE 300 ML (10 FL. OZ.) BLUE BOTTLES RINSE, ORAL, ANTIBACTERIAL (BY PHYSICAL MEANS) NTO 01Z
    902815 GUM(R) PERIOSHIELD ORAL HEALTH RINSE 300 ML (10 FL. OZ.) BLUE BOTTLES RINSE, ORAL, ANTIBACTERIAL (BY PHYSICAL MEANS) NTO
    902816 GUM(R) PERIOSHIELD ORAL HEALTH RINSE 300 ML (10 FL. OZ.) BLUE BOTTLES RINSE, ORAL, ANTIBACTERIAL (BY PHYSICAL MEANS) NTO
    902817 GUM(R) PERIOSHIELD ORAL HEALTH RINSE 300 ML (10 FL. OZ.) BLUE BOTTLES RINSE, ORAL, ANTIBACTERIAL (BY PHYSICAL MEANS) NTO
    902818 GUM(R) PERIOSHIELD ORAL HEALTH RINSE 300 ML (10 FL. OZ.) BLUE BOTTLES RINSE, ORAL, ANTIBACTERIAL (BY PHYSICAL MEANS) NTO
    902821 GUM(R) PERIOSHIELD ORAL HEALTH RINSE 300 ML (10 FL. OZ.) BLUE BOTTLES RINSE, ORAL, ANTIBACTERIAL (BY PHYSICAL MEANS) NTO
    902822 GUM(R) PERIOSHIELD ORAL HEALTH RINSE 300 ML (10 FL. OZ.) BLUE BOTTLES RINSE, ORAL, ANTIBACTERIAL (BY PHYSICAL MEANS) NTO
    902823 GUM(R) PERIOSHIELD ORAL HEALTH RINSE 300 ML (10 FL. OZ.) BLUE BOTTLES RINSE, ORAL, ANTIBACTERIAL (BY PHYSICAL MEANS) NTO
    902824 GUM(R) PERIOSHIELD ORAL HEALTH RINSE 300 ML (10 FL. OZ.) BLUE BOTTLES RINSE, ORAL, ANTIBACTERIAL (BY PHYSICAL MEANS) NTO

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other