MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-03-31 for K2 SENSATION C4 S27 R K2P0427R manufactured by Ossur.
[5684004]
Prosthetic patient walking upstairs when the prosthetic foot came off. Pt started to fall but was caught prior to falling.
Patient Sequence No: 1, Text Type: D, B5
[13037049]
Final evaluation of product completed (b)(6) 2015.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003764610-2015-00006 |
| MDR Report Key | 4658761 |
| Report Source | 05 |
| Date Received | 2015-03-31 |
| Date of Report | 2015-03-25 |
| Date of Event | 2014-12-30 |
| Date Mfgr Received | 2015-01-29 |
| Date Added to Maude | 2015-05-14 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | K2 SENSATION C4 S27 R |
| Generic Name | COMPONENT, EXTERNAL, LIMB, ANKLE/FOOT |
| Product Code | ISH |
| Date Received | 2015-03-31 |
| Returned To Mfg | 2015-01-09 |
| Model Number | K2P0427R |
| Catalog Number | K2P0427R |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| 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 | 2015-03-31 |