BEUDAMED
    FDA Adverse Event Injury Summary report: N

    16-5301-0 MICROPORE-SURGICAL TAPE 1X10YDS

    MDR report key: 24581161 · Received March 11, 2026

    Report

    Report Number
    MW5185110
    Event Type
    Injury
    Date Received
    March 11, 2026
    Date of Event
    March 3, 2026
    Report Date
    March 6, 2026
    Manufacturer
    SOLVENTUM US LLC.
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS PATIENT REPORTED EXPERIENCING ITCHY SKIN WHEN USING THE PAPER TAPE THAT WAS INCLUDED WITH THE SUPPLIES DELIVERED ON THE FIRST SHIPMENT DATED (B)(6) 2026 (ORDER #(B)(4), DELIVERY NOTE (B)(4)). THE FRESENIUS TECHNICIAN DOCUMENTED THE PATIENT¿S CONCERN REGARDING SKIN IRRITATION ASSOCIATED WITH THE TAPE. "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
    637672 16-5301-0 MICROPORE-SURGICAL TAPE 1X10YDS TAPE AND BANDAGE, ADHESIVE KGX SOLVENTUM US LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown