BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERIOSHIELD ORAL RINSE

    MDR report key: 12151029 · Received July 12, 2021

    Report

    Report Number
    1413787-2021-00010
    Event Type
    Injury
    Date Received
    July 12, 2021
    Date of Event
    April 26, 2021
    Report Date
    July 6, 2021
    Product Code
    NTO
    PMA / PMN Number
    K053166
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A RECALL PRODUCT.

    Description of Event or Problem · 1

    PATIENT WAS ADMITTED TO HOSPITAL WITH RESPIRATORY ISSUES AFTER USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052700 PERIOSHIELD ORAL RINSE ORAL RINSE NTO 1775P

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR Hospitalization