BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOPCARE

    MDR report key: 20363405 · Received October 3, 2024

    Report

    Report Number
    1038758-2024-00025
    Event Type
    Injury
    Date Received
    October 3, 2024
    Date of Event
    September 9, 2024
    Report Date
    October 3, 2024
    Manufacturer
    EUROMED, INC.
    Product Code
    NAD
    UDI-DI
    00036800467187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AS OF 9/30/2024 MANUFACTURER HAS COMPLETED THEIR INVESTIGATION WITH NO ISSUES FOUND. 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 DATED 07/22/2024, THE CONSUMER STATED THAT THE PRODUCT TORE OFF HER SKIN, AND SHE HAD TO GO TO MEDI MERGE TO TREAT IT. ON THE COMPLETED CIR RECEIVED FROM THE CONSUMER ON 09/09/2024, THE CONSUMER STATES THAT THE BANDAGE ON HER SKIN WAS FINE FOR A DAY, THEN PARTIALLY LOOSENED. WHEN SHE TRIED TO REMOVED IT AFTER ONE DAY, IT RIPPED HER SKIN OFF, AND SHE ENDED UP WITH AN OPEN WOUND. SHE HAD TO GO TO MED MERGE CENTER TO HAVE THE WOUND CLEANED AND TREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1325583 TOPCARE FAST HEALING HYDROCOLLOID GEL BANDAGES NAD EUROMED, INC. UPC#036800467187 00182709 00036800467187

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other| O