BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPORE-SURGICAL TAPE 1X10YDS

    MDR report key: 25015231 · Received April 27, 2026

    Report

    Report Number
    MW5187343
    Event Type
    Injury
    Date Received
    April 27, 2026
    Date of Event
    April 6, 2026
    Report Date
    April 23, 2026
    Manufacturer
    SOLVENTUM US LLC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    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 02/04/2026 (ORDER (B)(4), DELIVERY NOTE (B)(4)). THE (B)(6) 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
    1055108 MICROPORE-SURGICAL TAPE 1X10YDS TAPE AND BANDAGE, ADHESIVE KGX SOLVENTUM US LLC 10717743

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown