MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-06-01 for VOSS PRONE POSITIONER P-3901 manufactured by Voss Medical Products.
[14871042]
After long procedure, patient noted to have "swelling" of nose and early signs of a pressure sore on nose.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5011277 |
| MDR Report Key | 1398180 |
| Date Received | 2009-06-01 |
| Date of Report | 2009-06-01 |
| Date of Event | 2009-04-22 |
| Date Added to Maude | 2009-06-09 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VOSS PRONE POSITIONER |
| Generic Name | HEAD REST |
| Product Code | KIL |
| Date Received | 2009-06-01 |
| Model Number | P-3901 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VOSS MEDICAL PRODUCTS |
| Manufacturer Address | 4235 CENTERGATE SAN ANTONIO TX 78217 US 78217 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-06-01 |