Brand Name | C-LEG KNEE JOINT |
Type of Device | EXTERNAL ABOVE KNEE PROSTHESIS |
Manufacturer (Section D) |
OTTO BOCK HEALTHCARE PRODUCTS GMBH |
brehmstrasse 16 |
vienna, vienna 1110 |
AU 1110 |
|
Manufacturer (Section G) |
OTTO BOCK HEALTHCARE PRODUCTS GMBH |
brehmstrasse 16 |
|
vienna, vienna 1110 |
AU
1110
|
|
Manufacturer Contact |
reinhard
wolkerstorfer
|
brehmstrasse 16 |
vienna, vienna 1110
|
AU
1110
|
|
MDR Report Key | 5436160 |
MDR Text Key | 38227650 |
Report Number | 9615892-2016-00003 |
Device Sequence Number | 1 |
Product Code |
ISW
|
Combination Product (y/n) | N |
Reporter Country Code | FR |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
02/10/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Model Number | 3C88-2 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 11/10/2015 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/29/2016 |
Initial Date FDA Received | 02/15/2016 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 06/02/2014 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |