BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDIJECTOR CHOICE

    MDR report key: 187878 · Received September 18, 1998

    Report

    Report Number
    2182861-1998-00002
    Event Type
    Other
    Date Received
    September 18, 1998
    Date of Event
    May 8, 1998
    Report Date
    May 12, 1998
    Manufacturer
    MEDI-JECT CORP.
    Product Code
    KZE
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PT WAS ADMITTED TO THE EMERGENCY ROOM 5/8/98 DUE TO HYPERGLYCEMIA. HIS BLOOD SUGAR WAS 300. PT HAD RED BLOTCHES UNDERNEATH SKIN AND FELT HARD TO TOUCH. PT ALSO EXPERIENCED WETNESS AFTER HIS INJECTION ON HIS SKIN. THE NEEDLE FREE SYRINGE USED WAS LOT #11915.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDIJECTOR CHOICE NEEDLE FREE SYRINGE KZE MEDI-JECT CORP. 300036-001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization