BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERITONEAL DIALYSIS CATHETER

    MDR report key: 23726731 · Received December 4, 2025

    Report

    Report Number
    MW5179952
    Event Type
    Injury
    Date Received
    December 4, 2025
    Report Date
    December 2, 2025
    Manufacturer
    UNKNOWN
    Product Code
    FKO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    RECEIVED AN EMAIL RESPONSE FROM (B)(6) ON (B)(6) 2025 CONFIRMING THAT THE PATIENT WAS ABLE TO COMPLETE TREATMENT ON THE REPORTED DAY. THE PDRN STATED THE PATIENT WENT INTO THE HOSPITAL. THE ADMISSION DATE WAS ON (B)(6) 2025 DUE TO SLOW DRAINS AND CATHETER MIGRATION TO THE PATIENT'S PELVIS. THE PATIENT WAS DISCHARGED ON (B)(6) 2025 AND READMITTED ON (B)(6) 2025. THE PDRN STATED THE PATIENT'S SYMPTOMS BEFORE EACH HOSPITALIZATION WERE INCOMPLETE DRAINS. THE PDRN STATED THE ISSUE IS NOT RELATED TO THE PD TREATMENT OR (B)(6) PRODUCT. THE PDRN STATED THE PATIENT DID NOT CHANGE MODALITY AS HE STAYS IN PERITONEAL DIALYSIS UNDERWENT PD TREATMENTS. PDRN STATED THE PATIENT IS CURRENTLY EVALUATED BY A SURGEON FOR A NEW PD CATHETER. THERE WAS HOSPITALIZATION DUE TO SLOW DRAIN AND CATHETER MIGRATION. 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
    2863219 PERITONEAL DIALYSIS CATHETER CATHETER, PERITONEAL DIALYSIS, SINGLE USE FKO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown