BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERIOSHIELD ORAL RINSE

    MDR report key: 12172530 · Received July 15, 2021

    Report

    Report Number
    1413787-2021-00011
    Event Type
    Injury
    Date Received
    July 15, 2021
    Date of Event
    June 30, 2021
    Report Date
    June 30, 2021
    Product Code
    NTO
    PMA / PMN Number
    K053166
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A RECALL PRODUCT.

    Description of Event or Problem · 1

    PATIENT USED PRODUCT AFTER HAVING THEIR TOOTH PULLED IN (B)(6) 2021 AND EXPERIENCED SEVERE INFECTION IN THEIR JAW. PATIENT HAS BEEN ON ANTIBIOTICS FOR ABOUT 3 MONTHS AND HAS BEEN HOSPITALIZED TWICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1072354 PERIOSHIELD ORAL RINSE ORAL RINSE NTO 1775P 04Z

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization DAILY ANTIBIOTICS (VERBATIM)