BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPORE-SURGICAL TAPE 1X10YDS

    MDR report key: 21634282 · Received March 18, 2025

    Report

    Report Number
    MW5167784
    Event Type
    Injury
    Date Received
    March 18, 2025
    Report Date
    March 14, 2025
    Manufacturer
    SOLVENTUM US LLC / 3M COMPANY
    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 (B)(6) CUSTOMER SERVICE TO REPORT THAT THE MICROPORE-SURGICAL TAPE THAT SHE GETS, MAKES HER ITCH. SHE IS CONCERNED SHE MAY POSSIBLY BE ALLERGIC. THE (B)(6) CUSTOMER SERVICE REPRESENTATIVE ADVISED HER TO REACH OUT TO THE NURSE FOR ADVICE. NO FURTHER INFORMATION WAS PROVIDED. 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
    1212741 MICROPORE-SURGICAL TAPE 1X10YDS TAPE AND BANDAGE, ADHESIVE KGX SOLVENTUM US LLC / 3M COMPANY 106218637

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown