BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PD CATHETER

    MDR report key: 24964985 · Received April 22, 2026

    Report

    Report Number
    MW5187231
    Event Type
    Injury
    Date Received
    April 22, 2026
    Date of Event
    March 23, 2026
    Report Date
    April 20, 2026
    Manufacturer
    UNKNOWN
    Product Code
    FJS
    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 PATIENT IS CURRENTLY IN THE HOSPITAL AND THE PATIENT'S WIFE IS REQUESTING A NEW CYCLER DUE TO ALL THE DRAINING ISSUES IN THE LAST COUPLE MONTHS. REFER TO QSN # (B)(4). THE PATIENT'S HOSPITALIZATION WAS DUE TO A PD CATHETER MALFUNCTION. THE PD CATHETER WAS REMOVED BECAUSE IT WAS NOT FUNCTIONING, AND THE PATIENT HAS NOW BEEN TRANSFERRED TO THE CENTER FOR ONGOING TREATMENT. NO FURTHER INFORMATION COULD BE 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
    357550 PD CATHETER CATHETER, PERITONEAL, LONG-TERM INDWELLING FJS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown