BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAREONE

    MDR report key: 25159687 · Received May 13, 2026

    Report

    Report Number
    1038758-2026-00011
    Event Type
    Injury
    Date Received
    May 13, 2026
    Date of Event
    April 14, 2026
    Report Date
    May 13, 2026
    Manufacturer
    EUROMED, INC.
    Product Code
    NAD
    UDI-DI
    00041520078261
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AS OF 05/04/2026, 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

    ACCORDING TO THE INITIAL REPORT RECEIVED ON APRIL 7, 2026, THE CONSUMER STATED THAT THE PRODUCT CAUSED HER SKIN TO BREAK OUT IN THE AREAS WHERE THE BANDAGES WERE APPLIED. THE CONSUMER CONFIRMED THAT SHE SOUGHT MEDICAL ATTENTION ON (B)(6), 2026. THE PHYSICIAN PRESCRIBED MUPIROCIN 2% OINTMENT TO BE APPLIED THREE TIMES DAILY FOR 7 DAYS. ON THE COMPLETED CONSUMER INFORMATION REPORT (CIR) RECEIVED ON APRIL 28, 2026, THE CONSUMER STATED THAT SHE HAD USED THESE BANDAGES PREVIOUSLY WITHOUT EXPERIENCING ANY PROBLEMS. THE CONSUMER REPORTED USING THE BANDAGES ON HER LEGS AND FACE, SPECIFICALLY ON THE LEFT SIDE OF HER LIP. AFTER REMOVING THE BANDAGES FROM HER LEGS, SHE NOTICED RED MARKS AT THE APPLICATION SITES. ON HER FACE, THE CONSUMER REPORTED REDNESS AND A BREAKOUT AT THE APPLICATION SITE, WHICH SHE DESCRIBED AS RESEMBLING A CHEMICAL BURN. CONSUMER STATED THAT SYMPTOMS DID NOT CORRECT AFTER SHE STOPPED USING THE PRODUCT, AS SCARRING REMAINED AT THE APPLICATION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339685 CAREONE ASSORTED ADVANCED HEALING PREMIUM BANDAGES NAD EUROMED, INC. UPC# 041520078261 244927 00041520078261

    Patients

    Seq Age Sex Outcome Treatment
    1