BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMUNITY SUBCUTANEOUS DELIVERY SYSTEM FOR REMODULIN

    MDR report key: 20192497 · Received September 10, 2024

    Report

    Report Number
    MW5159487
    Event Type
    Injury
    Date Received
    September 10, 2024
    Report Date
    September 9, 2024
    Manufacturer
    DEKA RESEARCH & DEVELOPMENT CORP.
    Product Code
    QJY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PATIENT BEGAN THERAPY WITH REMODULIN (TREPROSTINIL SODIUM, CONCENTRATION 5.0 MG/ML) DELIVERED VIA REMUNITY [SELF-FILLED] PUMP ON (B)(6) 2024 FOR SECONDARY PULMONARY ARTERIAL HYPERTENSION. THE CURRENT DOSE WAS REPORTED AS 0.012 G/KG. THE PATIENT¿S REMUNITY REMODULIN SUBCUTANEOUS QUICKSET SITE WAS COMING OUT (DEVICE DISLOCATION), SO IT WAS CHANGED TO A NEW SITE. ON (B)(6) 2024, 19 DAYS AFTER INITIATING SQ REMODULIN, THE PATIENT WAS ADMITTED TO HOSPITAL FOR KIDNEYS SHUTTING DOWN (ACUTE KIDNEY INJURY, HOSPITALIZED AND MEDICALLY SIGNIFICANT) AND HE GOT DISCHARGED FROM HOSPITAL ON (B)(6) 2024. THE REPORTER DID NOT PROVIDE CAUSALITY FOR THE EVENT OF ACUTE KIDNEY INJURY. 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
    1515794 REMUNITY SUBCUTANEOUS DELIVERY SYSTEM FOR REMODULIN INFUSION PUMP, DRUG SPECIFIC, PHARMACY-FILLED QJY DEKA RESEARCH & DEVELOPMENT CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown