BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLICKFINE 32GX4MM DONGBAO 7ER

    MDR report key: 18761497 · Received February 22, 2024

    Report

    Report Number
    3002806818-2024-00010
    Event Type
    Injury
    Date Received
    February 22, 2024
    Date of Event
    December 3, 2023
    Report Date
    February 22, 2024
    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 WENT TO THE HOSPITAL TO PURCHASE THE NEEDLE AND COMPLETED AN INSULIN INJECTION AT HOME. RED BLEEDING SPOTS WAS OBSERVED ON THE INJECTION AREA, SO SHE STOPPED TO USING THE NEEDLE. SEVERAL TESTING AND DOCUMENTS WERE REVIEWED: BIOBURDEN REPORT, ENDOTOXIN REPORT, BIOCOMPATIBIILTY TESTING, MANUFACTURING RECORDS. HOWEVER, NO ABNORMALITIES WERE FOUND.

    Description of Event or Problem · 0

    THE PATIENT WENT TO THE HOSPITAL TO PURCHASE THE NEEDLE AND COMPLETED AN INSULIN INJECTION AT HOME. RED BLEEDING SPOTS WAS OBSERVED ON THE INJECTION AREA, SO SHE STOPPED TO USING THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129555 CLICKFINE 32GX4MM DONGBAO 7ER PEN NEEDLE FMI YPSOMED AG CLICKFINE 32GX4MM DONGBAO 7ER 221618-02

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other