BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON LLC DERMABOND ADVANCED

    MDR report key: 23224078 · Received October 6, 2025

    Report

    Report Number
    MW5176964
    Event Type
    Injury
    Date Received
    October 6, 2025
    Date of Event
    September 16, 2025
    Report Date
    October 2, 2025
    Manufacturer
    ETHICON, INC.
    Product Code
    MPN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ETHICON LLC DERMABOND ADVANCED WAS UTILIZED TO CLOSE SKIN INCISIONS. DEVELOPED ERYTHEMA AND ITCHING AROUND THE 4 INCISIONS. I WAS INSTRUCTED TO GENERIC ZYRTEC AND BENADRYL WITHOUT IMPROVEMENT. I WAS THEN PRESCRIBED A MEDROL DOSE PACK WHICH I AM CURRENTLY TAKING. I HAVE BEEN ADMINISTERED "SKIN GLUE" ON PREVIOUS SURGERY WITHOUT ANY ADVERSE REACTION. MY ALLERGIES INCLUDE A LATEX SENSITIVITY, NOT ANAPHYLACTIC. I WOULD LIKE TO KNOW THE INGREDIENTS OF THE PRODUCT AS I PLAN TO SEE AN ALLERGIST/IMMUNOLOGIST, BUT ETHICON HAS NOT RESPONDED TO ME YET. SURGEON APPLIED TO INCISIONS TO ADHERE THE SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1867604 ETHICON LLC DERMABOND ADVANCED TISSUE ADHESIVE FOR THE TOPICAL APPROXIMATION OF SKIN MPN ETHICON, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Other ASA 81 MG.| B-COMPLEX.| BIOTIN. | CALCIUM.| COLCHICINE.| IBUPROFEN.| MAGNESIUM.| MEDIAL DOSE PACK.| METOPROLOL.| RALOXIFENE.| ROSUVASTATIN.| VIT D3. | VITAMINS.