FDA Adverse Event
Injury
Summary report: N
VOSS PRONEPOSITIONER
MDR report key: 2667151
·
Received November 21, 2008
Report
- Report Number
- 1643116-2008-00001
- Event Type
- Injury
- Date Received
- November 21, 2008
- Date of Event
- March 5, 2008
- Report Date
- November 21, 2008
- Manufacturer
- VOSS MEDICAL PRODUCTS
- Product Code
- KIL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE PT GOT VISUAL DISABILITY ON BOTH EYES AFTER A PROLONGED PERIOD OF ORTHOPAEDIC SURGERY USING THE PRONEPOSITIONER. IT WAS FOUND OUT AFTER THE PT AWOKE FROM ANESTHESIA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VOSS PRONEPOSITIONER | HEAD REST | KIL | VOSS MEDICAL PRODUCTS | P-3901 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |