MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2009-06-01 for VOSS PRONE POSITIONER P-3901 manufactured by Voss Medical Products.
[2769354]
After long procedure, pt noted having "swelling" of nose and early signs of a pressure sore on nose.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2651311 |
MDR Report Key | 2651311 |
Report Source | 99 |
Date Received | 2009-06-01 |
Date of Report | 2009-06-01 |
Date of Event | 2009-04-22 |
Date Facility Aware | 2009-04-22 |
Report Date | 2009-04-22 |
Date Reported to Mfgr | 2009-05-14 |
Date Added to Maude | 2012-07-13 |
Event Key | 0 |
Report Source Code | User Facility report |
Manufacturer Link | N |
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 | 3 |
Event Location | 3 |
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 Age | NA |
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 |