BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLICKFINE 32GX4MM DONGBAO 7ER

    MDR report key: 18724284 · Received February 16, 2024

    Report

    Report Number
    3002806818-2024-00008
    Event Type
    Injury
    Date Received
    February 16, 2024
    Date of Event
    August 17, 2023
    Report Date
    February 16, 2024
    Manufacturer
    YPSOMED AG
    Product Code
    FMI
    PMA / PMN Number
    K171984
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER COMPLETING THE INSULIN INJECTION FOR THE PATIENT, THE PATIENT FELT PAIN AT THE INJECTION SITE. THE NURSE GAVE HIM A HOT COMPRESS AND HIS SYMPTOMS IMPROVED AFTERWARDS. REVIEW OF MANUFACTURING SHOWED NO ABNORMALITIES OR DEVIATIONS FROM THE VALIDATED MANUFACTURING PROCESS FOR THE MAIN BATCH 211210. IN-PROCESS CONTROL FOR THE NEEDLE TIP TO THE CANNULA IS 100% COMPLETED BEFORE THE INNER PROTECTIVE CAP IS FITTED. NO ISSUES COULD BE FOUND.

    Description of Event or Problem · 0

    AFTER COMPLETING THE INSULIN INJECTION FOR THE PATIENT, THE PATIENT FELT PAIN AT THE INJECTION SITE. THE NURSE GAVE HIM A HOT COMPRESS AND HIS SYMPTOMS IMPROVED AFTERWARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387609 CLICKFINE 32GX4MM DONGBAO 7ER PEN NEEDLE FMI YPSOMED AG CLICKFINE 32GX4MM DONGBAO 7ER 211210-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other