Brand Name | PILLCAM |
Type of Device | SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE |
Manufacturer (Section D) |
GIVEN IMAGING LTD., YOQNEAM |
yetsira 13 street |
yoqneam 20692 |
|
Manufacturer (Section G) |
GIVEN IMAGING LTD., YOQNEAM |
yetsira 13 street |
|
yoqneam 20692 |
|
Manufacturer Contact |
amy
beeman
|
161 cheshire lane, suite 100 |
plymouth, MN 55441
|
7632104064
|
|
MDR Report Key | 8262150 |
MDR Text Key | 133753395 |
Report Number | 9710107-2019-00026 |
Device Sequence Number | 1 |
Product Code |
NEZ
|
UDI-Device Identifier | 07290101362227 |
UDI-Public | 07290101362227 |
Combination Product (y/n) | N |
Reporter Country Code | IN |
PMA/PMN Number | K123864 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign,user faci |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
04/01/2019 |
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 | 04/06/2019 |
Device Model Number | FGS-0400 |
Device Catalogue Number | FGS-0400 |
Device Lot Number | 37495U |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/07/2019 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
12/21/2018
|
Initial Date FDA Received | 01/18/2019 |
Supplement Dates Manufacturer Received | 03/11/2019
|
Supplement Dates FDA Received | 04/01/2019
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 10/06/2017 |
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 |
|
|