Brand Name | ICAST |
Manufacturer (Section D) |
ATRIUM MEDICAL CORP. |
hudson NH |
|
Manufacturer Contact |
lori
gosselin, sr, specialist
|
5 wentworth dr. |
hudson, NH 03051
|
6038801433
|
|
MDR Report Key | 3763680 |
MDR Text Key | 4484012 |
Report Number | 1219977-2014-00127 |
Device Sequence Number | 1 |
Product Code |
JCT
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K050814 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
03/21/2014 |
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 | 10/31/2015 |
Device Model Number | 85450 |
Device Catalogue Number | 85450 |
Device Lot Number | 10858970 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/21/2014
|
Initial Date FDA Received | 04/03/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/01/2012 |
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 |
Treatment | COOK INTRODUCER SHEATH 6FR X ANSEL; ROSEN GUIDEWIRE .035 X 260 |
Patient Outcome(s) |
Required Intervention;
|
|
|