BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DB LSE

    MDR report key: 12126514 · Received July 7, 2021

    Report

    Report Number
    3004130086-2021-00002
    Event Type
    Malfunction
    Date Received
    July 7, 2021
    Date of Event
    June 18, 2021
    Report Date
    June 21, 2021
    Manufacturer
    EPS BIO TECHNOLOGY CORP.
    Product Code
    FMK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN THE CUSTOMER TURNS THE BLUE TIP TO FREE THE NEEDLE HE PULLS OUT THE COMPLETE METAL PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029356 DB LSE LANCET FMK EPS BIO TECHNOLOGY CORP. 100780001 200619

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention