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 | 8729721 |
MDR Text Key | 149064660 |
Report Number | 9710107-2019-00276 |
Device Sequence Number | 1 |
Product Code |
FFT
|
UDI-Device Identifier | 07290101363064 |
UDI-Public | 07290101363064 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K102543 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
user facility |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
06/24/2019 |
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? |
No
|
Initial Date Manufacturer Received |
06/04/2019 |
Initial Date FDA Received | 06/24/2019 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 05/25/2014 |
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 Age | 83 YR |
Patient Weight | 66 |
|
|