BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMUNITY PUMP

    MDR report key: 16313025 · Received February 6, 2023

    Report

    Report Number
    MW5114747
    Event Type
    Injury
    Date Received
    February 6, 2023
    Report Date
    February 2, 2023
    Manufacturer
    DEKA RESEARCH AND DEVELOPMENT
    Product Code
    QJY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT REPORTED THAT ABOUT A WEEK AGO SHE STARTED TO EXPERIENCE SEVERE HEADACHES. PER MD REQUEST, SHE WENT TO THE HOSPITAL ON (B)(6) 2022 FOR TESTING DUE TO THE PAIN AND WENT HOME THE NEXT DAY. PATIENT IS CURRENTLY TITRATING ON RERNODULIN VIA REMUNITY PUMP SELF MIX WHICH COULD BE CAUSING THE HEADACHES. PATIENT HAS BEEN TAKING EXCEDRIN MIGRAINE TO HELP ALLEVIATE THE PAIN. MD IS AWARE. NO OTHER INFORMATION PROVIDED AT THIS TIME. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2312601 REMUNITY PUMP INFUSION PUMP, DRUG-SPECIFIC, PHARMACY-FILLED QJY DEKA RESEARCH AND DEVELOPMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization AMBRISENTAN| REMODULIN