BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP, INFUSION

    MDR report key: 14143341 · Received April 19, 2022

    Report

    Report Number
    3012307300-2022-06635
    Event Type
    Injury
    Date Received
    April 19, 2022
    Report Date
    June 20, 2023
    Manufacturer
    NULL
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: PRODUCT INFORMATION WAS UPDATED.

    Description of Event or Problem · 0

    PATIENT HAD A RASH ON HER SKIN WHERE THE PREVIOUS SQ REMODULIN SITE WAS AFTER 4 DAYS SO CHANGED TO NEW SITE TODAY. THIS MORNING NOTICED THAT THE SITE WAS LEAKING. REMODULIN AND SHE WAS HAVING SOME SHORTNESS OF BREATH AND WEAKNESS. HER NEW SITE IS NOW ALARMING BLOCKAGE DETECTED. HER SITE HAD ASLO SKIN IRRITATION SO SHE IS USING A NEW DRESSING. NO FURTHER DETAILS PROVIDED. REMODULIN DOSE:30 NG/KG/ MIN SUBCUTANEOUS. CONTINUOUS. LOT NUMBER: 2101981. EXPIRATION DATE: 11/30/2022. INDICATION: PRIMARY PULMONARY ARTERIAL HYPERTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705032 PUMP, INFUSION PUMP, INFUSION FRN

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other