BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVS HEALTH

    MDR report key: 18274682 · Received December 6, 2023

    Report

    Report Number
    1038758-2023-00032
    Event Type
    Injury
    Date Received
    December 6, 2023
    Date of Event
    November 8, 2023
    Report Date
    December 6, 2023
    Manufacturer
    EUROMED, INC.
    Product Code
    NAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AS OF 12/01/2023 ASO REVIEWED RECORDS OF BIOCOMPATIBILITY TESTS WITH NO ISSUES NOTED. REFER TO SECTION B.6 OF THIS REPORT FOR FURTHER DETAILS.

    Description of Event or Problem · 0

    ON THE INITIAL REPORT ON 11/ 08/2023, THE CONSUMER STATED THAT THE PRODUCT CAUSED AN ALLERGIC REACTION. THE CONSUMER WENT TO THE ER; HE WAS PRESCRIBED A STEROID AND ANTI-FUNGAL CREAM TO HELP WITH THE ITCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2136675 CVS HEALTH ADVANCE HEALING HYDROCOLLOID BANDAGES NAD EUROMED, INC. UPC#050428276037

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other