FDA Adverse Event
Injury
Summary report: N
HANA ORTHOPEDIC SURGERY TABLE
MDR report key: 14284236
·
Received May 4, 2022
Report
- Report Number
- 2921578-2022-00007
- Event Type
- Injury
- Date Received
- May 4, 2022
- Report Date
- June 2, 2022
- Manufacturer
- MIZUHO OSI
- Product Code
- JEA
- UDI-DI
- 00842430108747
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 0
BASED ON COMMUNICATION WITH THE USER FACILITY, IT WAS CONCLUDED THAT NO INCIDENT HAS OCCURED.
Description of Event or Problem · 0
IT WAS REPORTED THAT A PATIENT MAY HAVE FALLEN OR ALMOST FALLEN OFF AN OPERATING TABLE.
Description of Event or Problem · 0
IT WAS REPORTED THAT A PATIENT MAY HAVE FALLEN OR ALMOST FALLEN OFF AN OPERATING TABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1839595 | HANA ORTHOPEDIC SURGERY TABLE | OPERATING TABLE | JEA | MIZUHO OSI | 6875 | 00842430108747 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |