FDA Adverse Event
Malfunction
Summary report: N
GEI
MDR report key: 972420
·
Received April 16, 2007
Report
- Report Number
- 1527736-2007-02742
- Event Type
- Malfunction
- Date Received
- April 16, 2007
- Report Date
- April 6, 2007
- Product Code
- GEI
- PMA / PMN Number
- K002981
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GEI | GEI | Y45T20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |