FDA Adverse Event
Malfunction
Summary report: N
STINGRAY DSR. SOFTWARE VERSION 1,3.2.3.
MDR report key: 949095
·
Received August 31, 2004
Report
- Report Number
- 1318879-2004-00001
- Event Type
- Malfunction
- Date Received
- August 31, 2004
- Date of Event
- August 12, 2004
- Report Date
- August 24, 2004
- Manufacturer
- INFIMED, INC.
- Product Code
- LLZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STINGRAY DSR. SOFTWARE VERSION 1,3.2.3. | DIGITAL RADIOGRAPHIC IMAGING LSYSTEM | LLZ | INFIMED, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Other |