FDA Adverse Event
Injury
Summary report: N
PRODIGY ADVANCE
MDR report key: 1437566
·
Received August 12, 2009
Report
- Report Number
- 2124823-2009-00028
- Event Type
- Injury
- Date Received
- August 12, 2009
- Date of Event
- July 17, 2009
- Report Date
- July 17, 2009
- Manufacturer
- GE LUNAR CORP.
- Product Code
- KGI
- PMA / PMN Number
- K982267
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE INSTALLATION INSTRUCTIONS WAS COMPLETED, AND THE INSTRUCTIONS WERE FOUND TO BE ADEQUATE.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE INSTALLATION OF THE PRODIGY ADVANCE SYSTEM A PT TRIPPED AND FELL ON THE PORTION OF THE SYSTEM THAT WAS IN THE HALL. THE PT WAS TAKEN TO THE ER WHERE SHE RECEIVED SIX STITCHES ON HER HAND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRODIGY ADVANCE | KGI | GE LUNAR CORP. | PRODIGY ADVANCE | PA+302760 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |