BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVS HEALTH

    MDR report key: 23401831 · Received October 28, 2025

    Report

    Report Number
    1038758-2025-00027
    Event Type
    Injury
    Date Received
    October 28, 2025
    Date of Event
    September 30, 2025
    Report Date
    October 28, 2025
    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 (B)(6) 2025, THE MANUFACTURER HAS COMPLETED THE INVESTIGATION WITH NO ISSUES IDENTIFIED. ASO REVIEWED THE BIOCOMPATIBILITY TEST RECORDS, AND NO CONCERNS WERE NOTED. PER THE PRODUCT LABELING, THE DEVICE IS CONTRAINDICATED FOR USE ON ANY INFECTED AREAS. FOR ADDITIONAL DETAILS, REFER TO SECTION B.6 OF THIS REPORT.

    Description of Event or Problem · 0

    ACCORDING TO THE INITIAL REPORT RECEIVED ON (B)(6) 2025, THE CONSUMER STATED THAT HE APPEARED TO HAVE EXPERIENCED AN ALLERGIC REACTION TO THE PRODUCT. IN THE COMPLETED CUSTOMER INFORMATION REQUEST (CIR) FORM SUBMITTED ON (B)(6) 2025, THE CONSUMER REPORTED DEVELOPING A RASH OVER THE ENTIRE AREA WHERE THE PRODUCT WAS APPLIED. HE HAD USED THE PRODUCT TO COVER AN INSECT BITE THAT HAD BECOME INFECTED. HE REMOVED THE PRODUCT AND CLEANED THE AREA. THE DOCTOR EXAMINED IT AS IT TOOK A LONG TIME TO CLEAR. THE CONSUMER CONFIRMED THAT THE SYMPTOMS CORRECTED AFTER HE STOPPED USING THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2352086 CVS HEALTH WATERPROOF HYDROCOLLOID BLEMISH PATCHES NAD EUROMED, INC. UPC#050428473115

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other