FDA Adverse Event
Injury
Summary report: N
HANA OPERATING ROOM TABLE
MDR report key: 3232370
·
Received November 7, 2012
Report
- Report Number
- 2921578-2012-00020
- Event Type
- Injury
- Date Received
- November 7, 2012
- Date of Event
- July 19, 2012
- Report Date
- November 2, 2012
- Manufacturer
- MIZUHO ORTHOPEDIC SYSTEMS, INC.
- Product Code
- JEA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
WORKING TO CONTACT HOSPITAL AND COMPLAINANT, AS THE COMPLAINT DID NOT COME DIRECTLY FROM HOSPITAL.
Description of Event or Problem · 1
A NURSE IN THE OPERATING ROOM IN (B)(6), CONTACTED MIZUHO OSI TO DISCUSS THE 6875 TABLE AND THAT WHILE SHE USED THE DEVICE SHE HURT HER BACK ON (B)(6) 2012.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HANA OPERATING ROOM TABLE | OPERATING ROOM TABLE | JEA | MIZUHO ORTHOPEDIC SYSTEMS, INC. | 6875 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |