BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKINCOTE

    MDR report key: 23257516 · Received October 9, 2025

    Report

    Report Number
    MW5177133
    Event Type
    Injury
    Date Received
    October 9, 2025
    Date of Event
    September 23, 2025
    Report Date
    September 30, 2025
    Manufacturer
    DYNAREX CORPORATION
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    501
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2025 AT 9:15 AM PATIENT COMPLAINED OF ITCHING BEHIND EARS BILATERALLY. MILD RASH, IRRITATION, AND REDNESS NOTED BEHIND EARS BILATERALLY. SKIN INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301740 SKINCOTE DRESSING,WOUND,DRUG FRO DYNAREX CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Male Other