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 3C88-2 manufactured by Otto Bock Healthcare Products Gmbh.
[38227650]
Patient was walking on the street when the c-leg became suddenly free on stance phase (no more breaks) and she fell. No injuries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615892-2016-00003 |
| MDR Report Key | 5436160 |
| 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 | 2015-11-10 |
| Model Number | 3C88-2 |
| 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 |