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 2019-04-12 for C-LEG 3C98-3 manufactured by Otto Bock Healthcare Products Gmbh.
[141724682]
Device is currently not available for evaluation; supplemental report will be submitted after evaluation of all device components is completed.
Patient Sequence No: 1, Text Type: N, H10
[141724683]
Patient fall - knee did not extend. Her 24mth serviced unit was only returned to her in february this year. Patient reports that the c-leg failed to 'follow through' whilst walking in the kitchen recently, resulting in a significant fall, requiring hospitalization.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615892-2019-00006 |
| MDR Report Key | 8508152 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2019-04-12 |
| Date of Report | 2019-04-04 |
| Date of Event | 2019-04-04 |
| Date Mfgr Received | 2019-10-29 |
| Device Manufacturer Date | 2016-06-22 |
| Date Added to Maude | 2019-04-12 |
| 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 |
| Generic Name | EXTERNAL ABOVE KNEE PROSTHESIS |
| Product Code | ISY |
| Date Received | 2019-04-12 |
| Returned To Mfg | 2019-08-22 |
| Model Number | 3C98-3 |
| Catalog Number | 3C98-3 |
| 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 | 2019-04-12 |