FDA Adverse Event
Malfunction
Summary report: N
JACKSON
MDR report key: 1352047
·
Received March 12, 2009
Report
- Report Number
- 1352047
- Event Type
- Malfunction
- Date Received
- March 12, 2009
- Date of Event
- March 11, 2009
- Report Date
- March 12, 2009
- Manufacturer
- MIZUHO OSI
- Product Code
- JEB
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MO, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
DURING SURGERY TO REPAIR A FEMUR FRACTURE THE PATIENT WAS ON THE JACKSON ORTHOPEDIC TABLE AND THE TRACTION UNIT BROKE ALLOWING THE PATIENT TO SLIDE OFF OF THE TABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JACKSON | TRACTION UNIT | JEB | MIZUHO OSI | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR |