BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPORE-SURGICAL TAPE 1X10YDS

    MDR report key: 24884089 · Received April 14, 2026

    Report

    Report Number
    MW5186838
    Event Type
    Injury
    Date Received
    April 14, 2026
    Date of Event
    February 25, 2026
    Report Date
    April 10, 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 (PD) PATIENT CONTACTED FRESENIUS CUSTOMER SERVICE TO REPORT THE MICROPORE SURGICAL TAPE. PATIENT STATED THAT THE PAPER TAPE CAUSED HER SKIN TO BE ITCHY. PATIENT HAS VERY SENSITIVE SKIN AND WEARING THE TAPE ALL DAY GIVE HER A REACTION. PATIENT ONLY RECEIVED IT ON HER FIRST DELIVERY 02/25 AND HAS NOT ORDERED SINCE DUE TO HER REACTION. 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
    929102 MICROPORE-SURGICAL TAPE 1X10YDS TAPE AND BANDAGE, ADHESIVE KGX SOLVENTUM US LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown