BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 20513275 · Received October 23, 2024

    Report

    Report Number
    3003442380-2024-29024
    Event Type
    Malfunction
    Date Received
    October 23, 2024
    Date of Event
    September 14, 2024
    Report Date
    September 24, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES ON (B)(6) 2024, IT WAS REPORTED THAT INFUSION WAS CANNULA WAS KINKED WITHIN 3 OR MORE HOURS AFTER INSERTION. THE INFUSION SET WAS OIN USE FOR 4 HOURS. CUSTOMER CHANGED SUPPLIES AS NECESSARY AND RESUMED INSULIN THERAPY NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33097 UNKNOWN UNKNOWN FPA UNOMEDICAL A/S UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Female