BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 21305973 · Received February 4, 2025

    Report

    Report Number
    MW5165628
    Event Type
    Injury
    Date Received
    February 4, 2025
    Report Date
    January 30, 2025
    Manufacturer
    INFUSYN THERAPEUTICS
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PATIENT REPORTS CONSTANT NUMBNESS AROUND THE PUMP POCKET AND DOWN THEIR POSTERIOR LEG AFTER FALLING. CATHETER OCCLUSION WAS NOTED. 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
    1060809 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK INFUSYN THERAPEUTICS 25184

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown