MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,consumer,health profession report with the FDA on 2015-07-10 for KIT SYMBIONIC LEG C2 S23 SMBL2230 manufactured by Ossur.
[17847872]
Amputee pt was walking downstairs, when she reached the bottom and turned, she claims the knee did not extend and she fell.
Patient Sequence No: 1, Text Type: D, B5
[18336396]
Product received in distribution center on (b)(6) 2015 - shipped to (b)(6) mfg facility for eval. Product current under eval. There is a discrepancy on the injury date as provided by (b)(6). The claim of injury date is (b)(6) 2015; however, the notification to us was (b)(6) 2015. We are working to get clarification of this info.
Patient Sequence No: 1, Text Type: N, H10
[31135121]
Patient Sequence No: 1, Text Type: N, H10
[31135122]
Amputee patient was walking downstairs, when she reached the bottom and turned, she claims the prosthetic knee did not extend and she fell.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003764610-2015-00011 |
| MDR Report Key | 4935828 |
| Report Source | 04,CONSUMER,HEALTH PROFESSION |
| Date Received | 2015-07-10 |
| Date of Report | 2015-09-08 |
| Date of Event | 2015-06-15 |
| Date Mfgr Received | 2015-06-09 |
| Date Added to Maude | 2015-07-24 |
| 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 | 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 |
| Manufacturer Street | GRJOTHALS 1-5 |
| 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 | KIT SYMBIONIC LEG C2 S23 |
| Generic Name | ASSEMBLY, KNEE/SHANK/ANKLE/FOOT, EXT |
| Product Code | ISW |
| Date Received | 2015-07-10 |
| Returned To Mfg | 2015-07-01 |
| Model Number | SMBL2230 |
| Catalog Number | SMBL2230 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSSUR |
| Manufacturer Address | GRJOTHALS 1-5 REYKJAVIK, 110 IC 110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-07-10 |