BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLICKFINE 32GX4MM DONGBAO 7ER

    MDR report key: 20854507 · Received December 5, 2024

    Report

    Report Number
    3002806818-2024-00024
    Event Type
    Injury
    Date Received
    December 5, 2024
    Date of Event
    September 25, 2024
    Report Date
    November 14, 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

    AFTER THE COMPLETION OF AN INSULIN SELF-INJECTION, THE LOCAL SKIN AREA WAS ITCHY WITH OBSERVED FLAKY ERYTHEMA. THE SYMPTOM IMPROVED AFTER THE PEN NEEDLE WAS REPLACED AND AN INTERVENTION OF A BENADRYL INJECTION OF 20MG WERE INTRAMUSCULARLY DELIVERED. SEVERAL TESTING AND DOCUMENTS WERE REVIEWED: BIOBURDEN REPORT, ENDOTOXIN REPORT, IRRADIATION CERTIFICATE, AND MANUFACTURING PROCESSES/RECORDS. HOWEVER, NO ABNORMALITIES WERE FOUND.

    Description of Event or Problem · 0

    AFTER THE COMPLETION OF AN INSULIN SELF-INJECTION, THE LOCAL SKIN AREA WAS ITCHY WITH OBSERVED FLAKY ERYTHEMA. THE SYMPTOM IMPROVED AFTER THE PEN NEEDLE WAS REPLACED AND AN INTERVENTION OF A BENADRYL INJECTION OF 20MG WERE INTRAMUSCULARLY DELIVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2487541 CLICKFINE 32GX4MM DONGBAO 7ER PEN NEEDLES FMI YPSOMED AG CLICKFINE 32GX4MM DONGBAO 7ER 231534-02

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention