MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-11-20 for POWER KNEE G2 PKN120007 PKN12007 manufactured by Ossur Iceland.
[31768215]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
[31768216]
Amputee patient using the power knee g2 while driving his car, observed smoke emitting from the battery pack. The patient proceeded to remove the battery and discard it. No injury or incident occured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003764610-2015-00014 |
| MDR Report Key | 5240526 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-11-20 |
| Date of Report | 2015-11-20 |
| Date of Event | 2015-07-17 |
| Date Mfgr Received | 2015-07-17 |
| Date Added to Maude | 2015-11-20 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. KAREN MONTES |
| Manufacturer Street | 27051 TOWNE CENTRE DRIVE |
| Manufacturer City | FOOTHILL RANCH CA 92610 |
| Manufacturer Country | US |
| Manufacturer Postal | 92610 |
| Manufacturer Phone | 9493823741 |
| Manufacturer G1 | OSSUR ICELAND |
| Manufacturer Street | GRJOTHALS 5 |
| Manufacturer City | REYKJAVIK, 110 |
| Manufacturer Country | IC |
| Manufacturer Postal Code | 110 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POWER KNEE G2 |
| Generic Name | ASSEMBLY, KNEE/SHANK/ANKLE/FOOT, EXTERNAL |
| Product Code | ISW |
| Date Received | 2015-11-20 |
| Model Number | PKN120007 |
| Catalog Number | PKN12007 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSSUR ICELAND |
| Manufacturer Address | GRJOTHALS 5 REYKJAVIK, 110 IC 110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-11-20 |