FDA Adverse Event
Other
Summary report: N
MEDI-JECT
MDR report key: 74315
·
Received February 25, 1997
Report
- Report Number
- 2182861-1997-00002
- Event Type
- Other
- Date Received
- February 25, 1997
- Date of Event
- February 14, 1997
- Report Date
- February 18, 1997
- 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 OF DEVICE EXPERIENCED A HYPOGLYCEMIC EPISODE WHICH REQUIRED HOSP.
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 |