BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSION DEVICES - UNKNOWN

    MDR report key: 19786371 · Received July 20, 2024

    Report

    Report Number
    3003442380-2024-15478
    Event Type
    Malfunction
    Date Received
    July 20, 2024
    Report Date
    July 20, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN SWEDEN. IT WAS REPORTED THAT THE PATIENT FACED INFUSIONS SET CANNULA TUBE TWISTING DURING THE NIGHT AS THE PATIENT SLEEPS. PATIENT SUFFERED FROM DEMENTIA. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2033724 INFUSION DEVICES - UNKNOWN INFUSION DEVICES - UNKNOWN FPA UNOMEDICAL A/S UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown