MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-01-29 for RHEO KNEE 3 RKN130003 manufactured by Ossur Hf.
[134336212]
The patient fell and broke his ribs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003764610-2019-00002 |
| MDR Report Key | 8284877 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-01-29 |
| Date of Report | 2019-03-12 |
| Date Mfgr Received | 2018-11-02 |
| Date Added to Maude | 2019-01-29 |
| 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 | KATLA AXELSDOTTIR |
| Manufacturer Street | GRJOTHALS 1-5 |
| Manufacturer City | REYKJAVIK, 110 |
| Manufacturer Country | IC |
| Manufacturer Postal | 110 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RHEO KNEE 3 |
| Generic Name | PROSTHETIC KNEE |
| Product Code | ISW |
| Date Received | 2019-01-29 |
| Model Number | RKN130003 |
| Catalog Number | RKN130003 |
| 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 HF |
| Manufacturer Address | GRJOTHALS 1-5 REYKJAVIK, 110 IC 110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-01-29 |