BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWONIX PAIN PUMP

    MDR report key: 24481475 · Received March 2, 2026

    Report

    Report Number
    MW5184550
    Event Type
    Malfunction
    Date Received
    March 2, 2026
    Report Date
    February 26, 2026
    Manufacturer
    INFUSYN THERAPEUTICS
    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

    PATIENT MENTIONED THAT THEY HAD A FLOWONIX PUMP ON 2021 AND THEY ARE WITH (B)(6), WELDING FOR THEM AND ABOUT 2 MONTHS LATER, IT "KILLED" THE PUMP. PATIENT SAID THAT THAT TIME THE WELDING MACHINE WAS A VERY HIGH FREQUENCY MACHINE. "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
    553134 FLOWONIX PAIN PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK INFUSYN THERAPEUTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown