BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPORE-SURGICAL TAPE 1X10YDS

    MDR report key: 23568761 · Received November 17, 2025

    Report

    Report Number
    MW5178945
    Event Type
    Injury
    Date Received
    November 17, 2025
    Date of Event
    October 6, 2025
    Report Date
    November 13, 2025
    Manufacturer
    SOLVENTUM US LLC.
    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 (B)(6) CUSTOMER SERVICE TO REPORT A 16-5301-0 - MICROPORE-SURGICAL TAPE 1X10YDS. THE PATIENT ASKED IF HER NURSE HAD PUT TRANSPARENT DRESSINGS ON HER PRESCRIPTION. I ADVISED THE PATIENT THAT SHE HAD. THE PATIENT STATED THAT SHE USED TO USE THE TAPE THAT WAS ON HER NEW PATIENT DELIVERY, BUT IT COMPLETELY RAVAGED HER SKIN. THE PATIENT STATED THAT IT LOOKS LIKE SOMEONE PUNCHED HER BECAUSE HER SKIN WAS BLACK AND BLUE FROM USING THE TAPE. SHE STATED IT BECAME SO IRRITATED AND HAD TO USE COCONUT OIL TO REPAIR HER SKIN. SHE STATED THAT SHE STILL USES THE TAPE, BUT ONLY TO TAPE THE GAUZE TO HER CATHETER AND NOT TO HER SKIN. NO RGA NEEDED BECAUSE THE PATIENT IS STILL USING THE TAPE. I SENT OUT THE BIOCLUSIVE TRANSPARENT DRESSINGS ON ORDER (B)(4). "THERE WAS PATIENT INVOLVEMENT AND". "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
    2881683 MICROPORE-SURGICAL TAPE 1X10YDS TAPE AND BANDAGE, ADHESIVE KGX SOLVENTUM US LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown