MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-04-21 for RHEO KNEE 3 RKIN130009 RKN130009 manufactured by Ossur Iceland.
[43209862]
Prosthetic patient wearing rheo knee 3 prosthetic limb fell down a set of stairs and hit her head. She was planning on seeking medical attention. No further details provided.
Patient Sequence No: 1, Text Type: D, B5
[45316414]
Patient Sequence No: 1, Text Type: N, H10
[45316415]
Prosthetic patient wearing rheo knee 3 prosthetic limb fell down a set of stairs and hit her head. Patient stated she was in a car accident the weekend before the incident and was on muscle relaxers when the incident occured and stated that may have been the contributing factor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003764610-2016-00004 |
| MDR Report Key | 5594037 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-04-21 |
| Date of Report | 2016-05-17 |
| Date of Event | 2016-03-21 |
| Date Mfgr Received | 2016-04-06 |
| Date Added to Maude | 2016-04-21 |
| 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 | RHEO KNEE 3 |
| Generic Name | ASSEMBLY, KNEE/SHANK/ANKLE/FOOT EXTERNAL |
| Product Code | ISW |
| Date Received | 2016-04-21 |
| Returned To Mfg | 2016-04-10 |
| Model Number | RKIN130009 |
| Catalog Number | RKN130009 |
| 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 ICELAND |
| Manufacturer Address | GRJOTHALS 5 REYKJAVIK, 110 IC 110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-04-21 |