Brand Name | BRAVO |
Type of Device | ELECTRODE, PH, STOMACH |
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 | 9336967 |
MDR Text Key | 167013507 |
Report Number | 9710107-2019-00557 |
Device Sequence Number | 1 |
Product Code |
FFT
|
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | K102543 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
11/18/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/18/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 12/30/2019 |
Device Model Number | FGS-0312 |
Device Catalogue Number | FGS-0312 |
Device Lot Number | 44056Q |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 11/01/2019 |
Date Device Manufactured | 12/30/2018 |
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 |
|
|