MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-12-19 for POWER KNEE II US PLUG PKN120007 manufactured by Ossur.
[16056637]
Prosthetic patient was walking down a flight of stairs and fell while wearing a power knee. He went to the emergency room - no injury or fractures were found. The patient was prescribed a higher dose of the pain medicine he was already taking.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2085446-2013-00006 |
| MDR Report Key | 3554818 |
| Report Source | 05 |
| Date Received | 2013-12-19 |
| Date of Report | 2013-12-19 |
| Date of Event | 2013-10-23 |
| Date Mfgr Received | 2013-11-26 |
| Date Added to Maude | 2014-01-28 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KAREN MONTES |
| Manufacturer Street | 27051 TOWNE CENTRE DRIVE |
| Manufacturer City | FOOTHILL RANCH CA 92610 |
| Manufacturer Country | US |
| Manufacturer Postal | 92610 |
| Manufacturer Phone | 9493823471 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POWER KNEE II US PLUG |
| Product Code | ISW |
| Date Received | 2013-12-19 |
| Model Number | PKN120007 |
| Catalog Number | PKN120007 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSSUR |
| Manufacturer Address | REYKJAVIK EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-12-19 |