Brand Name | V12 COVERED STENT |
Type of Device | COVERED STENT |
Manufacturer (Section D) |
ATRIUM MEDICAL CORP. |
hudson NH |
|
Manufacturer Contact |
lori
gosselin
|
5 wentworth dr. |
hudson, NH 03051
|
6038801433
|
|
MDR Report Key | 4122253 |
MDR Text Key | 15805018 |
Report Number | 1219977-2014-00312 |
Device Sequence Number | 1 |
Product Code |
MAF
|
Combination Product (y/n) | N |
Reporter Country Code | CA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Distributor |
Reporter Occupation |
Not Applicable
|
Type of Report
| Initial |
Report Date |
09/05/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 07/31/2017 |
Device Model Number | 85337 |
Device Catalogue Number | 85337 |
Device Lot Number | 212188 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
09/05/2014
|
Initial Date FDA Received | 09/18/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/01/2014 |
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) |
Required Intervention;
|
Patient Age | 72 YR |
|
|