BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLICKFINE 32GX4MM DONGBAO 7CT

    MDR report key: 18185147 · Received November 21, 2023

    Report

    Report Number
    3002806818-2023-00026
    Event Type
    Injury
    Date Received
    November 21, 2023
    Date of Event
    July 5, 2023
    Report Date
    November 21, 2023
    Manufacturer
    YPSOMED AG
    Product Code
    FMI
    PMA / PMN Number
    K171984
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT FELT PAIN DURING AN INSULIN INJECTION. MANUFACTURING REVIEW OF DOCUMENTS AND PENETRATION FORCE IN-PROCESS CONTROLS SHOWED NO ABNORMALITIES OR DEVIATIONS FROM THE VALIDATED MANUFACTURING PROCESS FOR THE MAIN BATCH 221452.

    Description of Event or Problem · 0

    THE PATIENT FELT PAIN DURING AN INSULIN INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1637282 CLICKFINE 32GX4MM DONGBAO 7CT PEN NEEDLE FMI YPSOMED AG CLICKFINE 32GX4MM DONGBAO 7CT 221452-02

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other