BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY

    MDR report key: 14679103 · Received June 13, 2022

    Report

    Report Number
    3016798778-2022-00002
    Event Type
    Malfunction
    Date Received
    June 13, 2022
    Date of Event
    May 12, 2022
    Report Date
    June 13, 2022
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS LLC
    Product Code
    QJY
    UDI-DI
    00850017421059
    PMA / PMN Number
    K202690
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    COMPLAINT (B)(4). PATIENT REPORTED TO THE SPECIALTY PHARMACY ON (B)(6) 2022 THAT DUE TO TWO OCCURRENCES OF LEAKING CASSETTES THE PATIENT RAN OUT OF CASSETTES; THE PATIENT WAS INSTRUCTED BY THE PHARMACIST TO SEEK MEDICAL ATTENTION TO CONTINUE REMODULIN THERAPY. THIS INFORMATION WAS REPORTED TO MILLYARD ADVANCED MEDICAL PRODUCTS LLC ON (B)(6) 2021. NO COMPONENTS ASSOCIATED WITH THE EVENT HAVE BEEN MADE AVAILABLE TO THE MANUFACTURER FOR FURTHER EVALUATION DESPITE MULTIPLE REQUESTS. DESPITE NO REPORT OF DEATH OR SERIOUS INJURY THIS ISSUE IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1490243 REMUNITY INFUSION PUMP QJY MILLYARD ADVANCED MEDICAL PRODUCTS LLC DKPI-11036-001 00850017421059

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Male Hospitalization