BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTOUCH

    MDR report key: 25322949 · Received May 28, 2026

    Report

    Report Number
    3005798905-2026-00023
    Event Type
    Malfunction
    Date Received
    May 28, 2026
    Date of Event
    May 20, 2026
    Report Date
    May 28, 2026
    Manufacturer
    BERPU MEDICAL TECHNOLOGY CO., LTD
    Product Code
    FMF
    PMA / PMN Number
    K102178
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    END USER STATES HIS NEW BOXES OF IS ARE NOW BENDING, STATES HE HAS NEVER HAD THIS ISSUE UNTIL THIS LOT. IS REPLACED, END USE LIVES OUTSIDE OF THE UNITED STATES WILL NOT BE REQUESTING PRODUCT BACK. INFORMED USER TO DISCARD OF IS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501400 EASYTOUCH INSULIN SYRINGE FMF BERPU MEDICAL TECHNOLOGY CO., LTD 75051

    Patients

    Seq Age Sex Outcome Treatment
    1