Brand Name | RESOLUTION 360 ULTRA CLIP |
Type of Device | HEMOSTATIC METAL CLIP FOR THE GI TRACT |
Manufacturer (Section D) |
BOSTON SCIENTIFIC CORPORATION |
300 boston scientific way |
marlborough MA 01752 |
|
Manufacturer (Section G) |
BOSTON SCIENTIFIC DE COSTA RICA S.R.L |
2546 calle primera |
propark, coyol |
alajuela |
CS
|
|
Manufacturer Contact |
carole
morley
|
300 boston scientific way |
marlborough, MA 01752
|
5086834015
|
|
MDR Report Key | 13224457 |
MDR Text Key | 283591834 |
Report Number | 3005099803-2022-00058 |
Device Sequence Number | 1 |
Product Code |
PKL
|
UDI-Device Identifier | 08714729997252 |
UDI-Public | 08714729997252 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K151802 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
01/11/2022 |
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 Model Number | M00521401 |
Device Catalogue Number | 2140 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/13/2021 |
Initial Date FDA Received | 01/11/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Life Threatening;
Required Intervention;
|