FDA Adverse Event
Other
Summary report: N
MEDI-JECT
MDR report key: 54210
·
Received December 3, 1996
Report
- Report Number
- 2182861-1996-00013
- Event Type
- Other
- Date Received
- December 3, 1996
- Date of Event
- November 17, 1996
- Report Date
- November 20, 1996
- Manufacturer
- MEDI-JECT CORP.
- Product Code
- KZE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
USER STATES HAVING A BLOOD GLUCOSE LEVEL OF 600. HE WAS HOSPITALIZED 11/17/96 AND RELEASED ON 11/19/96.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDI-JECT | C2 DME -NEEDLE-FREE DRUG DELIVERY DEVICE | KZE | MEDI-JECT CORP. | 100430-001 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Hospitalization |