BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERITONEAL DIALYSIS CATHETER

    MDR report key: 17528089 · Received August 12, 2023

    Report

    Report Number
    MW5135019
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    March 22, 2022
    Manufacturer
    UNKNOWN
    Product Code
    FJS
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE CATHETER USED BY THE PATIENT IS NOT A FRESENIUS DEVICE. THE MANUFACTURER OF THE CATHETER, OND FURTHER PRODUCT INFORMATION, IS UNKNOWN. (B)(4). 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
    870613 PERITONEAL DIALYSIS CATHETER CATHETER, PERITONEAL, LONG-TERM INDWELLING FJS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown