Brand Name | BRAVO |
Type of Device | BRAVO PH CAPSULE |
Manufacturer (Section D) |
GIVEN IMAGING LTD. |
hermon building, new industrial park |
po box 258 |
yokneam 20692 |
IS 20692 |
|
Manufacturer (Section G) |
GIVEN IMAGING LTD |
2 hacarmel street |
new industrial park |
yoqneam, 20692 |
IS
20692
|
|
Manufacturer Contact |
sharon
murphy
|
60 middletown avenue |
|
north haven, CT 06473
|
2034925267
|
|
MDR Report Key | 4475717 |
MDR Text Key | 5400868 |
Report Number | 9710107-2015-00006 |
Device Sequence Number | 1 |
Product Code |
FFT
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K002028 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility,user facility |
Reporter Occupation |
Not Applicable
|
Type of Report
| Initial,Followup |
Report Date |
01/20/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/22/2015 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 09/03/2015 |
Device Model Number | FGS-0313 |
Device Catalogue Number | FGS-0313 |
Device Lot Number | 26253Q |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/06/2015 |
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 09/07/2017 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 09/03/2014 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|