Brand Name | SMARTPILL |
Type of Device | GASTROINTESTINAL MOTILITY SYSTEM, CAPSULE |
Manufacturer (Section D) |
GIVEN IMAGING LTD., YOQNEAM |
yetsira 13 street |
yoqneam 20692 |
IL 20692 |
|
Manufacturer (Section G) |
GIVEN IMAGING LTD., YOQNEAM |
yetsira 13 street |
|
yoqneam 20692 |
IL
20692
|
|
Manufacturer Contact |
amy
beeman
|
161 cheshire lane, suite 100 |
plymouth, MN 55441
|
7632104064
|
|
MDR Report Key | 10585505 |
MDR Text Key | 208492135 |
Report Number | 9710107-2020-00457 |
Device Sequence Number | 1 |
Product Code |
NYV
|
UDI-Device Identifier | 04260167482712 |
UDI-Public | 04260167482712 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K092342 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
09/25/2020 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 06/15/2021 |
Device Model Number | 50100100 |
Device Catalogue Number | 50100100 |
Device Lot Number | 48810P |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/09/2020 |
Initial Date FDA Received | 09/25/2020 |
Date Device Manufactured | 12/30/2019 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|