FDA Adverse Event
Other
Summary report: N
*
MDR report key: 1251464
·
Received March 21, 2008
Report
- Report Number
- 2431314-2008-00001
- Event Type
- Other
- Date Received
- March 21, 2008
- Manufacturer
- BIODEX MEDICAL SYSTEMS, INC.
- Product Code
- KXJ
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THE ULTRASOUND TABLE WAS MFG IN FEBRUARY 1994. THE TABLE HAS BEEN IN USE FOR 14 YRS. WE CALLED AND SPOKE TO REP OF SECURITY. HE STATED TO BIODEX THE PT WAS OBESE AND PARALYZED AND COULD NOT SPEAK. TO REMOVE THE PT FROM THE TABLE THEY SLID THE PT OVER THE FOLDED SIDE RAIL. THE PT GOT A LACERATION AND STARTED TO BLEED AND DID NOT REQUIRE STITCHES TO STOP THE BLEEDING. THEY REMOVED THE SIDE RAIL FROM THE TABLE. THE OTHER RAIL IS STILL ON THE TABLE. REP STATED THAT IF YOU RUN YOUR HAND OVER THE RAIL, YOU WILL NOT GET CUT. WE REQUESTED THEY SEND US THE RAIL TO EVALUATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | * | KXJ | BIODEX MEDICAL SYSTEMS, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |