BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PD CATHETER

    MDR report key: 25014948 · Received April 27, 2026

    Report

    Report Number
    MW5187336
    Event Type
    Injury
    Date Received
    April 27, 2026
    Report Date
    April 22, 2026
    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

    IT WAS REPORTED THAT THIS PERITONEAL DIALYSIS (PD) PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2026 DUE TO AN INFECTION (UNSPECIFIED). THE PD CATHETER (NOT A (B)(6) PRODUCT) WAS REMOVED. THE PATIENT TRANSITIONED TO HEMODIALYSIS (HD). ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THE PATIENT¿S PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) STATED THE PATIENT REMAINED HOSPITALIZED AND THE CLINIC DID NOT HAVE ACCESS TO ANY RECORDS. THE CAUSE OF THE INFECTION WAS UNKNOWN. THE EXACT DIAGNOSIS WAS NOT PROVIDED. IT IS UNKNOWN WHAT TYPE OF INFECTION WAS DIAGNOSED. 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
    48150 PD CATHETER CATHETER, PERITONEAL DIALYSIS, SINGLE USE FKO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown