MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07,08 report with the FDA on 2008-11-21 for VOSS PRONEPOSITIONER P-3901 manufactured by Voss Medical Products.
[2838240]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1643116-2008-00001 |
| MDR Report Key | 2667151 |
| Report Source | 01,07,08 |
| Date Received | 2008-11-21 |
| Date of Report | 2008-11-21 |
| Date of Event | 2008-03-05 |
| Report Date | 2008-11-19 |
| Date Mfgr Received | 2008-11-19 |
| Date Added to Maude | 2012-07-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Street | 4235 CENTERGATE |
| Manufacturer City | SAN ANTONIO TX 78217 |
| Manufacturer Country | US |
| Manufacturer Postal | 78217 |
| Manufacturer Phone | 8002476294 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VOSS PRONEPOSITIONER |
| Generic Name | HEAD REST |
| Product Code | KIL |
| Date Received | 2008-11-21 |
| Model Number | P-3901 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VOSS MEDICAL PRODUCTS |
| Manufacturer Address | SAN ANTONIO TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2008-11-21 |