BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWONIX PUMP

    MDR report key: 24114500 · Received January 20, 2026

    Report

    Report Number
    MW5182411
    Event Type
    Malfunction
    Date Received
    January 20, 2026
    Report Date
    January 13, 2026
    Manufacturer
    FLOWONIX / INFUSYN THERAPEUTICS, LLC.
    Product Code
    LKK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT: PATIENT REPORTED THEY HAD A "FLUONIX" (TAKEN AS FLOWONIX) PUMP THAT WENT BAD ON THEM. IF YOU HAVE ANY QUESTIONS REGARDING THIS LETTER FOR MANUFACTURER NOTIFICATION, PLEASE DO NOT HESITATE TO CONTACT US. "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
    178216 FLOWONIX PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK FLOWONIX / INFUSYN THERAPEUTICS, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown