FDA Adverse Event
Other
Summary report: N
OVATION TABLE
MDR report key: 1413815
·
Received July 8, 2009
Report
- Report Number
- 2921578-2009-00009
- Event Type
- Other
- Date Received
- July 8, 2009
- Date of Event
- May 29, 2009
- Report Date
- July 7, 2009
- Manufacturer
- MIZUHO OSI
- Product Code
- JEA
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PT SUPINE ON FRACTURE TABLE AT THE CONCLUSION OF ORTHOPEDIC CASE, ATTENDED BY STAFF ON PT'S RIGHT SIDE, CONDE AND STRAP WAS REMOVED. PT SLID FROM RIGHT SIDE OF TABLE AND WAS SUPINE ON FLOOR. PT ANESTHESIA REVERSED, ALERT AND ORIENTED, RECEIVED TRAUMA CONSULT, SUSTAINED 10CM SOFT TISSUE POSTERIOR OCCIPUT. MONITORED CLOSELY IN ICU AND TRANSFERRED TO REHAB UNIT. PT HAD SIGNS OF RIGHT FOOT DROP, "UNRELATED TO FALL".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OVATION TABLE | ORTHOPEDIC OPERATING ROOM TABLE | JEA | MIZUHO OSI | 6310 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Hospitalization |