BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUM PERIO SHIELD

    MDR report key: 12377136 · Received August 26, 2021

    Report

    Report Number
    MW5103524
    Event Type
    Injury
    Date Received
    August 26, 2021
    Date of Event
    January 1, 2021
    Report Date
    August 24, 2021
    Product Code
    NTO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE (B)(4) - GUM - 1775R PERIOSHIELD ORAL HEALTH RINSE, 10 OUNCE BOTTLE USED THIS CONTAMINATED PRODUCT IN CONJUNCTION WITH A FACE MASK AND CAUSED INFECTIONS ON THE SKIN. REPORTED TO THE MANUFACTURER - REFERRED TO MANUFACTURER 6/28/2021 SAID WOULD RESPOND, NO RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272423 GUM PERIO SHIELD RINSE, ORAL, ANTIBACTERIAL (BY PHYSICAL MEANS) NTO "02A,02A,01A,02Z"

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention