BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISLAND DRESSING 50/BOX

    MDR report key: 25085389 · Received May 4, 2026

    Report

    Report Number
    MW5187658
    Event Type
    Injury
    Date Received
    May 4, 2026
    Report Date
    April 23, 2026
    Manufacturer
    UNK
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED FRESENIUS CUSTOMER SERVICE TO REPORT A 16-2210-0 - ISLAND DRESSING 50/BOX. THE PATIENT REPORTS HE MIGHT BE ALLERGIC TO THE ISLAND DRESSING GLUE AND WOULD LIKE TO TRY THE TEGADERM TRANSPARENT DRESSING INSTEAD. HE REPORTS THE ISLAND DRESSING LEAVES HIM FEELING ITCHINESS ON HIS SKIN THE NEXT DAY ONCE REMOVED. THERE WAS PATIENT REACTION REPORTED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515188 ISLAND DRESSING 50/BOX TAPE AND BANDAGE, ADHESIVE KGX UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown