BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DROPLET PEN NEEDLE

    MDR report key: 8373449 · Received February 27, 2019

    Report

    Report Number
    9613304-2019-00043
    Event Type
    Malfunction
    Date Received
    February 27, 2019
    Report Date
    February 6, 2019
    Manufacturer
    HTL-STREFA S.A.
    Product Code
    FMI
    UDI-DI
    05907996093069
    PMA / PMN Number
    K143437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SEEMS TO DRAG WHEN IT GOES IN. HE DESCRIBED IT AS 'CATCHING AND HANGING UP' AS IT GOES IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166994 DROPLET PEN NEEDLE PEN NEEDLE FMI HTL-STREFA S.A. 31G X 5MM Y56J2 05907996093069

    Patients

    Seq Age Sex Outcome Treatment
    1