BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM60 PUMP

    MDR report key: 12658185 · Received October 18, 2021

    Report

    Report Number
    MW5104706
    Event Type
    Malfunction
    Date Received
    October 18, 2021
    Report Date
    July 15, 2021
    Manufacturer
    REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    INDICATION: ANTIBODY DEFICIENCY WITH NEAR-NORMAL IMMUNOGLOBULINS OR WITH HYPERIMMUNOGLOBULINEMIA. SOLICITED: PATIENT REPORTED FREEDOM 60 PUMP IS BROKEN. NO ADDITIONAL INFORMATION PROVIDED WITH REGARD TO PATIENTS PRODUCT OR MEDICATION. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1550165 FREEDOM60 PUMP PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS F10050

    Patients

    Seq Age Sex Outcome Treatment
    1