BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM 60-PUMP

    MDR report key: 11841740 · Received May 17, 2021

    Report

    Report Number
    MW5101392
    Event Type
    Injury
    Date Received
    May 17, 2021
    Report Date
    May 12, 2021
    Manufacturer
    REPRO-MED SYSTEMS, INC., DBA KORU MEDICAL SYSTEMS
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    INBOUND CALL FROM (B)(6) AT MD OFFICE STATING PT CALLED HER ABOUT HIS PUMP. PT SAYS THE PUMP IS NOT WORKING CORRECTLY AND PUTTING 'PRESSURE' ON HIS ABDOMEN (SPECIFICS NOT REPORTED). (B)(6) DID SAY THAT THE PT HAS HAD PUMP FOR AWHILE, DATES UNKNOWN, SERIAL NUMBER INFORMATION UNKNOWN. NO ADDITIONAL INFORMATION OR DATES REPORTED. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735011 FREEDOM 60-PUMP PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC., DBA KORU MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1