Brand Name | POLARSHEATH |
Manufacturer (Section D) |
BOSTON SCIENTIFIC DE COSTA RICA S.R.L. |
302 parkway |
global park, la aurora |
heredia |
CS |
|
Manufacturer (Section G) |
BOSTON SCIENTIFIC CORPORATION |
302 parkway, global park |
|
la aurora - heredia |
CS
|
|
Manufacturer Contact |
timothy
degroot
|
4100 hamline avenue north |
dc a330 |
saint paul, MN 55112
|
6515826168
|
|
MDR Report Key | 10734712 |
MDR Text Key | 214639708 |
Report Number | 2134265-2020-14784 |
Device Sequence Number | 1 |
Product Code |
DRA
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
10/26/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 07/15/2021 |
Device Model Number | M004CRBS3050 |
Device Lot Number | 0025964240 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/02/2020 |
Initial Date FDA Received | 10/26/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/03/2020 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|