MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-03-14 for RESPIRONICS 1012624 manufactured by Respironics.
[20917207]
Pt developed unstageable pressure ulcer on the bridge of nose while wearing cpap and bipap mask. The pt wore the mask from (b)(6) 2010.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5019831 |
| MDR Report Key | 2023593 |
| Date Received | 2011-03-14 |
| Date of Report | 2011-03-14 |
| Date of Event | 2010-11-28 |
| Date Added to Maude | 2011-03-22 |
| 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 | RISK MANAGER |
| 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 | RESPIRONICS |
| Generic Name | FULL FACE CPAP MASK |
| Product Code | BYE |
| Date Received | 2011-03-14 |
| Model Number | 1012624 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESPIRONICS |
| Manufacturer Address | MURRYSVILLE PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-03-14 |