BEUDAMED
    FDA Adverse Event Summary report: N

    MEDI-JECTOR

    MDR report key: 50250 · Received November 19, 1996

    Report

    Report Number
    MW4001706
    Date Received
    November 19, 1996
    Report Date
    October 8, 1996
    Manufacturer
    MEDI-JECT CORP.
    Product Code
    KZE
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AS CAN BE SEEN FROM THE CALL LOG ABOVE, MEDI-JECT HAS ATTEMPTED TO WORK WITH THIS CUSTOMER TO ACHIEVE OPTIMAL PERFORMANCE OF THE PRODUCT. MEDI-JECT WILL UPGRADE THE UNIT WITH THE NEW NOZZLE DESIGN IF IT IS RETURNED. FURTHERMORE, IT IS IMPOSSIBLE TO DETERMINE IF THERE ARE ANY OTHER MECHANICAL PROBLEMS WITHOUT HAVING THE DEVICE TO TEST. FROM THE INFO PROVIDED TO MEDI-JECT, CO IS UNAWARE OF ANY MDR REPORTABLE EVENTS (I.E., SERIOUS INJURY OR DEATH RESULTING FROM USE OF THE DEVICE). THEREFORE, NO MDRS WERE FILED WITH FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDI-JECTOR AUTO INJECTOR KZE MEDI-JECT CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *