BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPORE-SURGICAL TAPE 1X10YDS

    MDR report key: 23061843 · Received September 16, 2025

    Report

    Report Number
    MW5176090
    Event Type
    Injury
    Date Received
    September 16, 2025
    Date of Event
    August 25, 2025
    Report Date
    September 9, 2025
    Manufacturer
    SOLVENTUM US LLC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS (PD) PATIENT (PT) CONTACTED CUSTOMER SERVICE SUPPORT TO REPORT THE MICROPORE-SURGICAL TAPE 1X10YDS. THE PATIENT REPORTED ON (B)(6) 2025 WITH PHARM TECH (B)(6) STATING THE MICROPORE PAPER TAPE PULLS SKIN OFF AND WANTS SILK OR CLOTH TAPE. SUBMITTING COMPLAINT (B)(4) DUE TO PATIENT FOLLOWING UP ON STATUS OF REPLACEMENT INQUIRY. THERE WAS PATIENT INVOLVEMENT, THE MICROPORE TAPE PULLS PATIENT¿S SKIN OFF 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
    2640331 MICROPORE-SURGICAL TAPE 1X10YDS TAPE AND BANDAGE, ADHESIVE KGX SOLVENTUM US LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown