BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMUNITY

    MDR report key: 19691017 · Received July 5, 2024

    Report

    Report Number
    MW5157086
    Event Type
    Injury
    Date Received
    July 5, 2024
    Report Date
    July 2, 2024
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS LLC.
    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

    PT REPORTS THAT THEY HAVE BEEN HOSPITALIZED SINCE (B)(6) 2024 DUE TO SWELLING IN THEIR LEGS AND ANKLES. ONSET/RESOLUTION DATES/STATUS OF SYMPTOM IS UNKNOWN. PT ALSO REPORTS THERE WAS BLOOD INSIDE THE TUBING WITH THEIR SQ SITE A COUPLE WEEKS AGO; WAS ADVISED THAT AS LONG AS THERE ARE NO PUMP ALARMS, THEY COULD KEEP SITE THE SAME. PT REPORTS THEY EVENTUALLY DEVELOPED CELLULITIS AT THEIR SQ SITE, WHICH HAD TO BE REMOVED WHILE AT THE HOSPITAL; PT IS NOW ON IV REMODULIN WHILE HOSPITALIZED. MD OFFICE IS AWARE OF SITE ISSUES AND HOSPITALIZATION. PT ALSO REPORTS THAT THEY OCCASIONALLY EXPERIENCE NASAL CONGESTION, WHICH HAS BEEN GOING ON FOR A WHILE (UNDETERMINED WHEN IT BEGAN). NO FURTHER INFO, DETAILS OR DATES AVAILABLE. SQ REMUNITY SELF-FILL PT TEMPORARILY ON IV THERAPY WHILE HOSPITALIZED. PT STARTED USING REMUNITY DEVICE (B)(6) 2024. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1459405 REMUNITY INFUSION PUMP, DRUG SPECIFIC, PHARMACY-FILLED QJY MILLYARD ADVANCED MEDICAL PRODUCTS LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization ADEMPAS.| OPSUMIT.| REMODULIN.