Brand Name | AIGIS-R LARGE |
Type of Device | MESH, SURGICAL, POLYMERIC |
Manufacturer (Section D) |
MEDTRONIC, INC. |
8200 coral sea street ne |
suites g, e |
mounds view,mn NJ 55112 |
|
Manufacturer (Section G) |
MEDTRONIC, INC. |
8200 coral sea street ne |
suites g, e |
mounds view,mn NJ 55112 |
|
Manufacturer Contact |
lisa
robertson
|
8200 coral sea st ne |
mounds view, MN 55112
|
7635262723
|
|
MDR Report Key | 7345411 |
MDR Text Key | 103163819 |
Report Number | 3005619263-2018-00036 |
Device Sequence Number | 1 |
Product Code |
FTL
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K130943 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
|
Type of Report
| Initial,Followup |
Report Date |
02/15/2019 |
1 Device was Involved in the Event |
|
0 Patients were Involved in the Event: |
|
Date FDA Received | 03/16/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
|
Device Expiration Date | 02/28/2018 |
Device Model Number | CMRM6133 |
Device Catalogue Number | CMRM6133 |
Device Lot Number | R094527 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 02/15/2019 |
Was Device Evaluated by Manufacturer? |
No Answer Provided
|
Date Device Manufactured | 01/05/2018 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
|
|