BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERITONEAL DIALYSIS CATHETER

    MDR report key: 23596299 · Received November 18, 2025

    Report

    Report Number
    MW5179041
    Event Type
    Injury
    Date Received
    November 18, 2025
    Date of Event
    November 1, 2025
    Report Date
    November 17, 2025
    Manufacturer
    UNKNOWN
    Product Code
    FKO
    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 REGISTERED NURSE (PD) REPORTED DURING A FOLLOW-UP CALL THAT THE PATIENT HAD AN OMENTAL WRAP ON HIS PD CATHETER. ACCORDING TO THE NURSE THE CATHETER WAS REPLACED (NO DATE PROVIDED) AND THE ISSUE WAS RESOLVED. 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
    313768 PERITONEAL DIALYSIS CATHETER CATHETER, PERITONEAL DIALYSIS, SINGLE USE FKO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown