FDA Adverse Event
Injury
Summary report: N
VC10 PUMP, 115 V
MDR report key: 869015
·
Received June 12, 2007
Report
- Report Number
- 2183680-2007-00011
- Event Type
- Injury
- Date Received
- June 12, 2007
- Report Date
- June 6, 2007
- Manufacturer
- GYRUS MEDICAL INC.
- Product Code
- JCX
- PMA / PMN Number
- K951972
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THE INSTRUMENT HAS NOT BEEN RETURNED TO GYRUS ACMI, INC. FOR EVALUATION TO DATE. WITHOUT THE INSTRUMENT RETURNED, A FULL INVESTIGATION CANNOT BE COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VC10 PUMP, 115 V | BERKELEY VC 10 VACUUM CURRETAGE SYSTEM | JCX | GYRUS MEDICAL INC. | VC-10 | 7026015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |