BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTOUCH

    MDR report key: 17885965 · Received October 6, 2023

    Report

    Report Number
    3005798905-2023-03140
    Event Type
    Malfunction
    Date Received
    October 6, 2023
    Date of Event
    October 5, 2023
    Report Date
    October 5, 2023
    Manufacturer
    FEEL TECH BIO CO., LTD.
    Product Code
    FMI
    PMA / PMN Number
    K112789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL TREND ANALYSIS FOR LOT 583317P WAS CONDUCTED, NO MALFUNCTIONS WERE FOUND. THIS IS THE ONLY COMPLAINT FOR LOT 583317P. FURTHER INVESTIGATION WILL BE CONDUCTED TO DETERMINE THE ROOT CAUSE OF COMPLAINT.

    Additional Manufacturer Narrative · 0

    RETAINED LOT 583317P INSPECTED FOR NEEDLE SHARPNESS, NO ABNORMALITIES FOUND DURING MANUFACTURING PROCESS.

    Description of Event or Problem · 0

    END USER REPORTS PEN NEEDLE IS BENDING DURING INJECTION INTO SKIN FROM LOT 583317P. END USER ALSO REPORTS THAT THE INSULIN DID NOT INJECT INTO THE SKIN BUT FOUND ON THE FLOOR.

    Description of Event or Problem · 0

    END USER REPORTS PEN NEEDLE IS BENDING DURING INJECTION INTO SKIN FROM LOT 583317P. END USER ALSO REPORTS THAT THE INSULIN DID NOT INJECT INTO THE SKIN BUT FOUND ON THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238365 EASYTOUCH PEN NEEDLE FMI FEEL TECH BIO CO., LTD. 583317P

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown