MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-08-01 for C-LEG KNEE JOINT 3C88-1 manufactured by Otto Bock Healthcare Products Gmbh.
[15103308]
The pt fell because the knee became free (unlocked). Left hip pain occurred.
Patient Sequence No: 1, Text Type: D, B5
[15477303]
No errors occurred during incoming inspection, all tests were passed. After evaluating the errors logged in the knee joint the valve responsible for controlling stance phase damping seemed to have positioning problems. One part of the servo unit was identified to bear some unintended coating on its surface, which could have caused the positioning problems.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615892-2014-00008 |
| MDR Report Key | 4121943 |
| Report Source | 08 |
| Date Received | 2014-08-01 |
| Date of Report | 2014-07-31 |
| Date of Event | 2014-06-12 |
| Date Mfgr Received | 2014-07-01 |
| Device Manufacturer Date | 2009-01-01 |
| Date Added to Maude | 2014-10-02 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | REINHARD WOLKERSTORFER |
| Manufacturer Street | KAISERSTRASSE 39 |
| Manufacturer City | WIEN 1070 |
| Manufacturer Country | AU |
| Manufacturer Postal | 1070 |
| Manufacturer Phone | 3152337866 |
| Single Use | 3 |
| Remedial Action | RP |
| 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 | 2014-08-01 |
| Model Number | 3C88-1 |
| 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 | OTTO BOCK HEALTHCARE PRODUCTS GMBH |
| Manufacturer Address | VIENNA AU |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-01 |