BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMUNITY SUBCUTANEOUS DELIVERY SYSTEM

    MDR report key: 20192615 · Received September 10, 2024

    Report

    Report Number
    MW5159498
    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 Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE PATIENT STARTED USING REMUNITY (SELF-FILL) DEVICE IN (B)(6) 2023, AND CURRENT DOSE WAS REPORTED AS 0.2024 G/KG, CONTINUOUS VIA SUBCUTANEOUS (SQ) ROUTE. THE PATIENT REPORTED THAT SILHOUETTE HAD CAUSED HER MAJOR BRUISING IN THE PAST (INFUSION SITE BRUISING). ACTION TAKEN WITH SQ REMODULIN WAS DOSE NOT CHANGED DUE TO THE EVENT OF INFUSION SITE BRUISING. AT THE TIME OF REPORTING, THE OUTCOME OF INFUSION SITE BRUISING WAS UNKNOWN. 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
    558417 REMUNITY SUBCUTANEOUS DELIVERY SYSTEM INFUSION PUMP, DRUG SPECIFIC, PHARMACY-FILLED QJY DEKA RESEARCH & DEVELOPMENT CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown REMODULIN.