FDA Adverse Event
Other
Summary report: N
6977 AXIS JACKSON TABLE
MDR report key: 2061033
·
Received March 16, 2011
Report
- Report Number
- 2921578-2011-00007
- Event Type
- Other
- Date Received
- March 16, 2011
- Date of Event
- February 16, 2011
- Report Date
- March 15, 2011
- Manufacturer
- MIZUHO ORTHOPEDIC SYSTEMS, INC.
- Product Code
- JEB
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INITIAL EVALUATION WILL ADVISE UPON RECEIPT.
Description of Event or Problem · 1
CUSTOMER CONCERNED WITH TABLES BILATERAL CHEST PAD USED FOR PRONE POSITIONING AS WHEN TABLE IS TILTED PTS ARE KNOWN TO SHIFT AND WITH THE ONE PT THERE WAS SKIN SHEARING. SURGERY WAS FOR APPROX 6 HOURS AND IT WAS NOTED THAT THE PT DEVELOPED REDNESS AND BRUISING ON THE INSIDE OF HER RIGHT BREAST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 6977 AXIS JACKSON TABLE | OPERATING ROOM TABLE | JEB | MIZUHO ORTHOPEDIC SYSTEMS, INC. | 6977 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR |