BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDI-JECT

    MDR report key: 116429 · Received August 29, 1997

    Report

    Report Number
    2182861-1997-00005
    Event Type
    Other
    Date Received
    August 29, 1997
    Date of Event
    July 1, 1929
    Report Date
    July 31, 1997
    Manufacturer
    MEDI-JECT CORPORATION
    Product Code
    EGM
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    USER OF MEDIJECTOR EXPERIENCED A HYPERGLYCEMIC EPISODE WHICH HE RELATED TO PARTIAL INSULIN DELIVERY DUE TO CRACKED NEEDLE FREE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDI-JECT MEDIJECTOR CHOICE-NEEDLE FREE DELIVERY SYSTEM. EGM MEDI-JECT CORPORATION 100430-001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *