MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-02-15 for C-LEG KNEE JOINT 3C98-2 manufactured by Otto Bock Healthcare Products Gmbh.
[38227645]
Stepping off equipment onto the ground. He had an issue earlier in the week, so the knee was set to high resistance, so that's what he was expecting but the knee released and he fell. No injuries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615892-2016-00001 |
| MDR Report Key | 5436154 |
| Report Source | DISTRIBUTOR |
| Date Received | 2016-02-15 |
| Date of Report | 2016-02-10 |
| Date Mfgr Received | 2016-01-29 |
| Device Manufacturer Date | 2014-06-02 |
| Date Added to Maude | 2016-02-15 |
| 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 | MR. REINHARD WOLKERSTORFER |
| Manufacturer Street | BREHMSTRASSE 16 |
| Manufacturer City | VIENNA, VIENNA 1110 |
| Manufacturer Country | AU |
| Manufacturer Postal | 1110 |
| Manufacturer G1 | OTTO BOCK HEALTHCARE PRODUCTS GMBH |
| Manufacturer Street | BREHMSTRASSE 16 |
| Manufacturer City | VIENNA, VIENNA 1110 |
| Manufacturer Country | AU |
| Manufacturer Postal Code | 1110 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | C-LEG KNEE JOINT |
| Generic Name | EXTERNAL ABOVE KNEE PROSTHESIS |
| Product Code | ISW |
| Date Received | 2016-02-15 |
| Returned To Mfg | 2015-12-15 |
| Model Number | 3C98-2 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OTTO BOCK HEALTHCARE PRODUCTS GMBH |
| Manufacturer Address | BREHMSTRASSE 16 VIENNA, VIENNA 1110 AU 1110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-15 |