MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2018-12-20 for C-LEG COMPACT KNEE JOINT 3C96-1 manufactured by Otto Bock Healthcare Products Gmbh.
[130980307]
Device evaluation in progress; supplemental report will be submitted after additional information has been obtained.
Patient Sequence No: 1, Text Type: N, H10
[130980308]
Patient has a very old compact knee the patient can't read the serial number off the knee. The knee has not been charged for a long time this fall may be that the patient is old and was not charging his device. The fall was not caused by any malfunction of the knee the patient was not charging his knee and it is stiff. Knee is not providing support. Sent from va. No charger could not assess knee for repair. Patient fell out of chair and fractured femur.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615892-2018-00033 |
| MDR Report Key | 8183472 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-12-20 |
| Date of Report | 2019-01-25 |
| Date of Event | 2018-10-22 |
| Date Mfgr Received | 2019-01-04 |
| Device Manufacturer Date | 2010-06-02 |
| Date Added to Maude | 2018-12-20 |
| 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, 1110 |
| Manufacturer Country | AU |
| Manufacturer Postal | 1110 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | C-LEG COMPACT KNEE JOINT |
| Generic Name | EXTERNAL ABOVE KNEE PROSTHESIS |
| Product Code | ISY |
| Date Received | 2018-12-20 |
| Returned To Mfg | 2018-11-21 |
| Model Number | 3C96-1 |
| Catalog Number | 3C96-1 |
| 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 | OTTO BOCK HEALTHCARE PRODUCTS GMBH |
| Manufacturer Address | BREHMSTRASSE 16 VIENNA, 1110 AU 1110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-12-20 |