BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTOUCH

    MDR report key: 19354580 · Received May 20, 2024

    Report

    Report Number
    3005798905-2024-03183
    Event Type
    Malfunction
    Date Received
    May 20, 2024
    Date of Event
    May 14, 2024
    Report Date
    May 20, 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 56706A WAS CONDUCTED, NO MALFUNCTIONS WERE FOUND. THIS IS THE ONLY COMPLAINT FOR LOT 56706A. FURTHER INVESTIGATION WILL BE CONDUCTED TO DETERMINE THE ROOT CAUSE OF COMPLAINT.

    Description of Event or Problem · 0

    USER STATES SYRINGES FROM LOT 56706A GETS BENT WHEN TRYING TO INJECT INSULIN. STATES ABOUT 5-6 FROM ONE PACK HAVE DONE THIS. SYRINGES ARE BEING USED WITH NOVALOG INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1767960 EASYTOUCH SYRINGE FMF FEEL TECH BIO CO., LTD. 56706A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown