FDA Adverse Event Other Summary report: N

MEDI-JECT

MDR report key: 130983 · Received November 7, 1997

Report

Report Number
2182861-1997-00010
Event Type
Other
Date Received
November 7, 1997
Report Date
October 28, 1997
Manufacturer
MEDI-JECT CORP.
Product Code
KZE
Report Source
Manufacturer report
Reporter Occupation
UNKNOWN

Narratives

Description of Event or Problem · 1

USER OF MEDI-JECTOR EXPERIENCED A HYPERGLYCEMIC EPISODE WHICH REQUIRED HOSPITALIZATION TWICE WITHIN THE PAST TWO MONTHS. DRY INJECTIONS REPORTED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MEDI-JECT C2-DME-NEEDLE FREE DELIVERY DEVICE KZE MEDI-JECT CORP. 300036-001 NA

Patients

Seq Age Sex Outcome Treatment
1 61 YR Hospitalization