FDA Adverse Event
Injury
Summary report: N
VOSS PRONE POSITIONER
MDR report key: 2651311
·
Received June 1, 2009
Report
- Report Number
- 2651311
- Event Type
- Injury
- Date Received
- June 1, 2009
- Date of Event
- April 22, 2009
- Report Date
- June 1, 2009
- Manufacturer
- VOSS MEDICAL PRODUCTS
- Product Code
- KIL
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
AFTER LONG PROCEDURE, PT NOTED HAVING "SWELLING" OF NOSE AND EARLY SIGNS OF A PRESSURE SORE ON NOSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VOSS PRONE POSITIONER | HEAD REST | KIL | VOSS MEDICAL PRODUCTS | P-3901 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |