BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORE VALUES

    MDR report key: 15008736 · Received July 13, 2022

    Report

    Report Number
    1038758-2022-00028
    Event Type
    Injury
    Date Received
    July 13, 2022
    Date of Event
    June 14, 2022
    Report Date
    July 13, 2022
    Manufacturer
    EUROMED, INC.
    Product Code
    NAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AS OF 07/08/2022 NO LOT OR RETURNED PRODUCT WERE PROVIDED THEREFORE MANUFACTURER IS UNABLE TO PERFORM AN INVESTIGATION. ASO REVIEWED RECORDS OF BIOCOMPATIBILITY TESTS WITH NO ISSUES NOTED.

    Description of Event or Problem · 0

    ON THE INITIAL REPORT ON 06/14/2022 CONSUMER STATED THAT PRODUCT CAUSED A REACTION SIMILAR TO CHEMICAL BURNS. CONSUMER STATED SOUGHT MEDICAL ATTENTION WITH HER DERMATOLOGIST DUE TO THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455267 CORE VALUES SMART-HEAL HYDROCOLLOID GEL BANDAGES NAD EUROMED, INC. UPC#017276235326

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other