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 | 8530206 |
MDR Text Key | 142466946 |
Report Number | 9710107-2019-00162 |
Device Sequence Number | 1 |
Product Code |
FFT
|
UDI-Device Identifier | 00290101363064 |
UDI-Public | 290101363064 |
Combination Product (y/n) | N |
Reporter Country Code | TU |
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 Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
06/05/2019 |
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 Model Number | FGS-0450 |
Device Catalogue Number | FGS-0450 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/13/2019 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/29/2019 |
Initial Date FDA Received | 04/18/2019 |
Supplement Dates Manufacturer Received | 05/14/2019
|
Supplement Dates FDA Received | 06/05/2019
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 08/26/2013 |
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 |
|
|