BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVS

    MDR report key: 22105935 · Received May 29, 2025

    Report

    Report Number
    1038758-2025-00012
    Event Type
    Injury
    Date Received
    May 29, 2025
    Date of Event
    May 2, 2025
    Report Date
    May 29, 2025
    Manufacturer
    EUROMED, INC.
    Product Code
    NAD
    UDI-DI
    00050428251966
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AS OF 05/29/2025, A MANUFACTURER HAS COMPLETED THEIR INVESTIGATION WITH NO ISSUES FOUND. ASO REVIEWED RECORDS OF BIOCOMPATIBILITY TESTS WITH NO ISSUES NOTED. REFER TO SECTION B6 OF THIS REPORT FOR FURTHER DETAILS.

    Description of Event or Problem · 0

    ACCORDING TO THE INITIAL REPORT DATED ON (B)(6) 2025, THE CONSUMER STATED THAT THE PRODUCT CAUSED HER BURNS. SHE HAD TO TAKE PREDNISONE, AND HER WOUND WAS STILL HEALING, AND SHE HAD A DISCOLORATION ON HER LEG. ON THE COMPLETED CIR RECEIVED VIA EMAIL FROM THE CONSUMER ON MAY 2, 2025, THE CONSUMER STATES THAT THE ENTIRE AREA OF THE BANDAGE WOUND HAS BLISTERS AND A RAISED SKIN RASH. THE CONSUMER VISITED THE DOCTOR AND WAS PRESCRIBED PREDNISONE 10MG TABLETS, HYDROXYZINE HCI 25MG, AND BETAMETHASONE VALERATE 0.1% TOPICAL CREAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587219 CVS HYDROCOLLOID GEL ADHESIVE PADS NAD EUROMED, INC. UPC#050428251966 00050428251966

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other