Brand Name | OTTO BOCK AXTION® PROSTHETIC FOOT |
Type of Device | 1E56 AXTION® PROSTHETIC FOOT |
Manufacturer (Section D) |
OTTO BOCK HEALTHCARE LP |
3820 west great lakes drive |
west valley city UT 84120 |
|
Manufacturer (Section G) |
OTTO BOCK HEALTHCARE LP |
3820 west great lakes drive |
|
west valley city UT 84120 |
|
Manufacturer Contact |
stephen
anderson
|
3820 west great lakes drive |
west valley city, UT 84120
|
8019746676
|
|
MDR Report Key | 7534224 |
MDR Text Key | 109376352 |
Report Number | 1721652-2018-00001 |
Device Sequence Number | 1 |
Product Code |
ISH
|
Combination Product (y/n) | N |
Reporter Country Code | PL |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other
|
Remedial Action |
Replace |
Type of Report
| Initial |
Report Date |
05/22/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/22/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Model Number | 1E56 |
Device Catalogue Number | 1E56=N28-5-P/0 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/21/2018 |
Date Manufacturer Received | 04/26/2018 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 07/18/2016 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Weight | 98 |