BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWONIX PAIN PUMP

    MDR report key: 24480473 · Received March 2, 2026

    Report

    Report Number
    MW5184521
    Event Type
    Malfunction
    Date Received
    March 2, 2026
    Report Date
    February 23, 2026
    Manufacturer
    INFUSYN THERAPEUTICS
    Product Code
    LKK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    CALLER STATED THEY ARE LOOKING FOR AN HCP PLACING (B)(6) PAIN PUMPS AS HE CURRENTLY HAS A FLOWONIX PAIN PUMP AND IS EXPERIENCING NUMEROUS ISSUES (LEAKING PUMP). 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
    553005 FLOWONIX PAIN PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK INFUSYN THERAPEUTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown