Brand Name | SIMPLICITY 3 BLUE COVER LOCKING LINER |
Type of Device | LINER |
Manufacturer (Section D) |
OTTO BOCK HEALTHCARE LP |
3820 west great lakes drive |
salt lake city UT 84120 |
|
Manufacturer (Section G) |
OTTO BOCK HEALTHCARE LP |
3820 west great lakes drive |
|
salt lake city UT 84120 |
|
Manufacturer Contact |
caleb
beck
|
3820 west great lakes drive |
salt lake city, UT 84120
|
8019746647
|
|
MDR Report Key | 4786335 |
MDR Text Key | 5852525 |
Report Number | 1721652-2015-00001 |
Device Sequence Number | 1 |
Product Code |
ISS
|
Combination Product (y/n) | N |
Reporter Country Code | FR |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional |
Reporter Occupation |
Other
|
Remedial Action |
Replace |
Type of Report
| Initial |
Report Date |
05/20/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/20/2015 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Other
|
Device Model Number | 6Y521=290-5 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/13/2015 |
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 12/17/2015 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 01/10/2014 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
|