FDA Adverse Event
Injury
Summary report: N
MEDI-JECTOR
MDR report key: 144737
·
Received January 15, 1998
Report
- Report Number
- 2182861-1997-00014
- Event Type
- Injury
- Date Received
- January 15, 1998
- Date of Event
- November 14, 1997
- Report Date
- November 19, 1997
- Manufacturer
- MEDI-JECT CORP.
- Product Code
- KZE
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
INITIATED MEDI-JECTOR USE ON 11/10/97. EXPERIENCED 3 EPISODES OF HYPOGLYCEMIC REACTIONS THE WEEK OF 11/10/97 RESULTING IN ONE ADMISSION TO THE EMERGENCY ROOM. EXPERIENCED EPILEPTIC SEIZURES AND BLOOD SUGARS RANGING IN THE 20'S. WAS TREATED AND RELEASED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDI-JECTOR | CHOICE NEEDLE-FREE DELIVERY SYSTEM | KZE | MEDI-JECT CORP. | 300036-001 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Hospitalization |