Type of Device | CLIP, IMPLANTABLE, REPROCESSED |
Manufacturer (Section D) |
STERILMED, INC. |
11400 73rd ave n |
maple grove MN |
|
Manufacturer Contact |
jason
anderson
|
11400 73rd ave n |
maple grove, MN 55446
|
7634888348
|
|
MDR Report Key | 6112695 |
MDR Text Key | 60433700 |
Report Number | 2134070-2016-00084 |
Device Sequence Number | 1 |
Product Code |
NMJ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K033579 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial,Followup |
Report Date |
12/15/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/18/2016 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Expiration Date | 06/10/2017 |
Device Model Number | ETHER320 |
Device Catalogue Number | ETHER320 |
Device Lot Number | 1951481 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/15/2016 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 12/15/2016 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 06/10/2016 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|