MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-01-26 for RHEO KNEE RKN120007 manufactured by Ossur Iceland.
[36892709]
Health professional does not believe the rheo knee failed or contributed to the event. We are anticipating the receipt of the product for analysis. Upon completion with analysis we will submit a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[36892710]
Above knee amputee patient fell and hit her head. She went to the emergency room and is expected to make a full recovery. She obtained a cut on her upper eyelid and received a dermabond stitch. Patient's prosthetist does not feel the rheo knee failed or caused the fall.
Patient Sequence No: 1, Text Type: D, B5
[40423581]
No product malfunction was identified that could have contributed to the incident.
Patient Sequence No: 1, Text Type: N, H10
[40423582]
Above knee amputee patient fell and hit her head. She went to the emergency room and is expected to make a full recovery. She obtained a cut on her upper eyelid and received a dermabond stitch. Patient's prosthetist does not feel the rheo knee failed or caused the fall.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003764610-2016-00002 |
| MDR Report Key | 5392210 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-01-26 |
| Date of Report | 2016-02-18 |
| Date of Event | 2015-12-25 |
| Date Mfgr Received | 2016-01-05 |
| Date Added to Maude | 2016-01-26 |
| 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 |
| Generic Name | ASSEMBLY, KNEE/SHANK/ANKLE/FOOT, EXTERNAL |
| Product Code | ISW |
| Date Received | 2016-01-26 |
| Returned To Mfg | 2016-01-08 |
| Model Number | RKN120007 |
| Catalog Number | RKN120007 |
| 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 | 2016-01-26 |