BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTOUCH

    MDR report key: 17166658 · Received June 20, 2023

    Report

    Report Number
    3005798905-2023-03123
    Event Type
    Malfunction
    Date Received
    June 20, 2023
    Date of Event
    June 15, 2023
    Report Date
    June 20, 2023
    Manufacturer
    BERPU MEDICAL TECHNOLOGY 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 593210 WAS CONDUCTED, NO MALFUNCTIONS WERE FOUND. THIS IS THE ONLY COMPLAINT FOR LOT 593210. FURTHER INVESTIGATION WILL BE CONDUCTED TO DETERMINE THE ROOT CAUSE OF COMPLAINT.

    Description of Event or Problem · 0

    END USER REPORTS THAT TWO BOXES OF PEN NEEDLES ITEM 831041 LOT 593210 ARE VERY UNCOMFORTABLE TO USE AS THOUGH THEY HAVE NO SILICON AND MAKING HER BLEED DURING USE. END USER ALSO COMMUNICATED THAT SOME OF THE PEN NEEDLE CAPS ARE DIFFICULT TO FIT AND ATTACH TO THE LANTUS SOLOSTAR INSULIN PEN BEING USED - WHICH IS NOT A NEW INSULIN PEN THAT SHE HAS BEGAN USING. ALSO MENTIONED, IF THE PEN NEEDLE IS ABLE TO FASTEN TO THE INSULIN PEN, REMOVING THE PEN NEEDLE IS DIFFICULT - "AS IF THE SIZE OF THE NEEDLE HUB IS TOO SMALL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458001 EASYTOUCH PEN NEEDLE FMI BERPU MEDICAL TECHNOLOGY CO., LTD 593210

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown