BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMODULIN PUMP

    MDR report key: 17080627 · Received June 6, 2023

    Report

    Report Number
    MW5118251
    Event Type
    Injury
    Date Received
    June 6, 2023
    Date of Event
    May 24, 2023
    Report Date
    June 2, 2023
    Manufacturer
    UNKNOWN
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT INITIALS: (B)(6). DATE OF AWARENESS: 6/2/23. REPORTER: HOSPITALIST. HOSPITALIZATION START DATE: (B)(6) 2023. HOSPITALIZATION END DATE: (B)(6) 2023. 45YO F WITH PMH PAH, CHRONIC COR PULMONALE, SLE, CHRONIC NEPHRITIS, AND OBESITY PRESENTED TO EMERGENCY ROOM AFTER REMODULIN PUMP FAILED. PATIENT WAS ADMITTED AND RESTARTED ON MEDICATION WHILE AWAITING NEW PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435058 REMODULIN PUMP PUMP INFUSION FRN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Hospitalization