Brand Name | UNKNOWN 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 | 11012429 |
MDR Text Key | 221557920 |
Report Number | 9710107-2020-00725 |
Device Sequence Number | 1 |
Product Code |
NEZ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
user facility |
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
12/15/2020 |
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 Model Number | UNKNOWN PILLCAM |
Device Catalogue Number | UNKNOWN PILLCAM |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
11/23/2020
|
Initial Date FDA Received | 12/15/2020 |
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) |
Hospitalization;
Required Intervention;
|
|
|