Brand Name | FOGARTY BILIARY BALLOON PROBE |
Type of Device | CATHETER, BILIARY, SURGICAL |
Manufacturer (Section D) |
EDWARDS LIFESCIENCES PR |
state rd indus pk 402 km 1.4 |
anasco PR 00610 |
|
Manufacturer (Section G) |
EDWARDS LIFESCIENCES PR |
state rd indus pk 402 km 1.4 |
|
anasco PR 00610 |
|
Manufacturer Contact |
brian
hurd-servin
|
1 edwards way |
irvine, CA 92614
|
9492506423
|
|
MDR Report Key | 5496010 |
MDR Text Key | 40646954 |
Report Number | 2015691-2016-00763 |
Device Sequence Number | 1 |
Product Code |
GCA
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | PREAMENDMENT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial |
Report Date |
02/10/2016 |
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 | 07/22/2017 |
Device Model Number | 410235F |
Device Lot Number | 60039810 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/16/2016 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/10/2016 |
Initial Date FDA Received | 03/11/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/22/2015 |
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 |