BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTOUCH

    MDR report key: 19480365 · Received June 6, 2024

    Report

    Report Number
    3005798905-2024-03187
    Event Type
    Malfunction
    Date Received
    June 6, 2024
    Date of Event
    May 30, 2024
    Report Date
    June 6, 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 LOTS 65215A AND 65841A WAS CONDUCTED, NO MALFUNCTIONS WERE FOUND. THIS IS THE ONLY COMPLAINT FOR LOTS 65215A AND 65841A. FURTHER INVESTIGATION WILL BE CONDUCTED TO DETERMINE THE ROOT CAUSE OF COMPLAINT.

    Description of Event or Problem · 0

    USER EMAILED STATING SHE HAS THREE BOXES OF SYRINGES OF ITEM 830165 LOTS 65215A AND 65841A THAT LOOK LIKE FAKES DUE TO THE COLORING OF THE POLYBAGS, PLUNGER IS ABLE TO BE PULLED OUT, AS AS WELL AS THE CANNULAS ARE DULL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1863460 EASYTOUCH SYRINGE FMF FEEL TECH BIO CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown