BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTOUCH

    MDR report key: 18926595 · Received March 18, 2024

    Report

    Report Number
    3005798905-2024-03168
    Event Type
    Malfunction
    Date Received
    March 18, 2024
    Date of Event
    February 27, 2024
    Report Date
    March 18, 2024
    Manufacturer
    FEEL TECH BIO CO., LTD.
    Product Code
    FMF
    PMA / PMN Number
    K102178
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL TREND ANALYSIS FOR LOT 63931A WAS CONDUCTED, NO MALFUNCTIONS WERE FOUND. THIS IS THE ONLY COMPLAINT FOR LOT 63931A. FURTHER INVESTIGATION WILL BE CONDUCTED TO DETERMINE THE ROOT CAUSE OF COMPLAINT.

    Additional Manufacturer Narrative · 0

    CMO INSPECTED RETAINED LOT 63931A NO ABNORMALITIES WERE FOUND DURING TESTING.

    Description of Event or Problem · 0

    END USER REPORTS THAT THE PLUNGER OF SYRINGE LOT 63931A IS FALLING OUT OF THE BARREL EASILY, CAUSING THE USER TO LOSE INSULIN. USER ALSO REPORTS THAT THE CANNULA IS "NOT COMFORTABLE".

    Description of Event or Problem · 0

    END USER REPORTS THAT THE PLUNGER OF SYRINGE LOT 63931A IS FALLING OUT OF THE BARREL EASILY, CAUSING THE USER TO LOSE INSULIN. USER ALSO REPORTS THAT THE CANNULA IS "NOT COMFORTABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2559549 EASYTOUCH SYRINGE FMF FEEL TECH BIO CO., LTD. 63931A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown