BEUDAMED
    FDA Adverse Event Other Summary report: N

    FLOWONIX PUMP

    MDR report key: 17383439 · Received July 21, 2023

    Report

    Report Number
    MW5119940
    Event Type
    Other
    Date Received
    July 21, 2023
    Report Date
    July 19, 2023
    Manufacturer
    FLOWONIX MEDICAL, INC.
    Product Code
    LKK
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT: PATIENT WAS HAVING A FLOWONIX PUMP REPLACED WITH A SYNC II PUMP AND THERE WAS FOUND TO BE A CATHETER KINK WITH THE FLOWONIX CATHETER. 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
    470490 FLOWONIX PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK FLOWONIX MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown