MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-02-26 for C-LEG KNEE JOINT 3C98-2=S manufactured by Otto Bock Healthcare Products Gmbh.
[39078406]
Device not returned yet. Supplemental report will be submitted after receipt and evaluation of device.
Patient Sequence No: 1, Text Type: N, H10
[39078407]
Patient golfing, transferred weight to c-leg and it buckled.
Patient Sequence No: 1, Text Type: D, B5
[53554925]
The device is not returned to ottobock. It is not possible to get the device back from the customer, over 6 attempts were made and documented. Therfore it was not possible to perform the product evaluation since 12/2015 (date of the event).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615892-2016-00004 |
| MDR Report Key | 5462619 |
| Report Source | DISTRIBUTOR |
| Date Received | 2016-02-26 |
| Date of Report | 2016-08-23 |
| Date of Event | 2015-06-12 |
| Date Mfgr Received | 2016-08-22 |
| Device Manufacturer Date | 2012-04-16 |
| Date Added to Maude | 2016-02-26 |
| 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 | 2016-02-26 |
| Model Number | 3C98-2=S |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2016-02-26 |