Brand Name | PILLCAM |
Type of Device | SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE |
Manufacturer (Section D) |
GIVEN IMAGING LTD., YOQNEAM |
yetsira 13 street |
yoqneam 20692 |
IS 20692 |
|
Manufacturer (Section G) |
GIVEN IMAGING LTD., YOQNEAM |
yetsira 13 street |
|
yoqneam 20692 |
IS
20692
|
|
Manufacturer Contact |
amy
beeman
|
161 cheshire lane, suite 100 |
plymouth, MN 55441
|
7632104064
|
|
MDR Report Key | 11581955 |
MDR Text Key | 242714796 |
Report Number | 9710107-2021-00164 |
Device Sequence Number | 1 |
Product Code |
NEZ
|
UDI-Device Identifier | 07290101364085 |
UDI-Public | 07290101364085 |
Combination Product (y/n) | N |
Reporter Country Code | NZ |
PMA/PMN Number | K123864 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
03/29/2021 |
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 | 03/02/2022 |
Device Model Number | FGS-0391 |
Device Catalogue Number | FGS-0391 |
Device Lot Number | 50956U |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/04/2021
|
Initial Date FDA Received | 03/29/2021 |
Date Device Manufactured | 09/02/2020 |
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 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 31 YR |
Patient Weight | 70 |
|
|