Brand Name | BRAVO PH MONITORING SYSTEM AND ACCESSORIES |
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 | 8576034 |
MDR Text Key | 143939298 |
Report Number | 9710107-2019-00198 |
Device Sequence Number | 1 |
Product Code |
FFT
|
UDI-Device Identifier | 07290101369707 |
UDI-Public | 07290101369707 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Nurse
|
Type of Report
| Initial,Followup |
Report Date |
05/17/2019 |
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 Expiration Date | 04/22/2020 |
Device Model Number | FGS-0635 |
Device Catalogue Number | FGS-0635 |
Device Lot Number | 42983F |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/14/2019 |
Initial Date FDA Received | 05/02/2019 |
Supplement Dates Manufacturer Received | 04/24/2019
|
Supplement Dates FDA Received | 05/17/2019
|
Date Device Manufactured | 10/22/2018 |
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 |
Patient Age | 59 YR |
Patient Weight | 117 |
|
|