BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDI-JECTOR VISION

    MDR report key: 380969 · Received March 7, 2002

    Report

    Report Number
    2182861-2002-00001
    Event Type
    Other
    Date Received
    March 7, 2002
    Date of Event
    February 5, 2002
    Report Date
    February 28, 2002
    Manufacturer
    ANTARES PHARMA, INC.
    Product Code
    KZE
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE PLASTIC NEEDLE-FREE SYRINGE USED ON THE MJ7 VISION INJECTOR BROKE, CAUSING A SKIN LACERATION. PATIENT SOUGHT MEDICAL ASSISTANCE AND RECEIVED TWO STITCHES TO CLOSE THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDI-JECTOR VISION NEEDLE-FREE INJECTOR KZE ANTARES PHARMA, INC. 300094-001 *

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR