MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-09-23 for POWER KNEE G2 KIT 2Y WARR PKN120002 manufactured by Ossur.
[4928082]
Above knee amputee patient fell while descending a flight of stairs, hit his head and required 7 stitches.
Patient Sequence No: 1, Text Type: D, B5
[12396076]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003764610-2014-00003 |
| MDR Report Key | 4146747 |
| Report Source | 01,05 |
| Date Received | 2014-09-23 |
| Date of Report | 2014-09-23 |
| Date of Event | 2014-05-14 |
| Date Mfgr Received | 2004-06-11 |
| Date Added to Maude | 2014-10-08 |
| 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 CENTER DRIVE |
| Manufacturer City | FOOTHILL RANCH CA 92610 |
| Manufacturer Country | US |
| Manufacturer Postal | 92610 |
| Manufacturer Phone | 9493823741 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POWER KNEE G2 KIT 2Y WARR |
| Generic Name | ASSEMBLY, KNEE/SHANK/ANKLE/FOOT, EXT |
| Product Code | ISW |
| Date Received | 2014-09-23 |
| Returned To Mfg | 2014-06-25 |
| Model Number | PKN120002 |
| Catalog Number | PKN120002 |
| Lot Number | HF510470 |
| Operator | LAY USER/PATIENT |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSSUR |
| Manufacturer Address | REYKJAVIK IC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-09-23 |