Brand Name | SUPER SHEATH INTRODUCER SHEATH |
Type of Device | INTRODUCER, CATHETER |
Manufacturer (Section D) |
BOSTON SCIENTIFIC CORPORATION |
two scimed place |
maple grove MN 55311 |
|
Manufacturer (Section G) |
MEDIKIT COMPANY LIMITED |
13-2 yushima 1-chome |
|
bunkyo-ku tokyo 113 |
JA
113
|
|
Manufacturer Contact |
jay
johnson
|
two scimed place |
maple grove, MN 55311
|
7634942574
|
|
MDR Report Key | 9954550 |
MDR Text Key | 187527324 |
Report Number | 2134265-2020-04460 |
Device Sequence Number | 1 |
Product Code |
DYB
|
UDI-Device Identifier | 14543527181829 |
UDI-Public | 14543527181829 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
04/13/2020 |
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 | 04/30/2020 |
Device Model Number | 28186 |
Device Catalogue Number | 28186 |
Device Lot Number | 17E23B6 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/02/2020 |
Initial Date FDA Received | 04/13/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/23/2017 |
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 |