Brand Name | LASSO® 2515 NAV ECO VARIABLE CATHETER |
Type of Device | CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING |
Manufacturer (Section D) |
BIOSENSE WEBSTER, INC. (JUAREZ) |
circuito interior norte #1820 |
parque industrial salvacar |
juarez, chihuahua 32599 |
MX 32599 |
|
Manufacturer (Section G) |
BIOSENSE WEBSTER, INC. (JUAREZ) |
circuito interior norte #1820 |
parque industrial salvacar |
juarez, chihuahua 32599 |
MX
32599
|
|
Manufacturer Contact |
shahe
garabedian
|
15715 arrow hwy |
irwindale, CA 91706
|
9098397362
|
|
MDR Report Key | 4808169 |
MDR Text Key | 5830115 |
Report Number | 9673241-2015-00340 |
Device Sequence Number | 1 |
Product Code |
DRF
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K113213 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Company Representative,company representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
01/07/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/01/2015 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 08/31/2017 |
Device Model Number | D-1343-01-S |
Device Catalogue Number | D134301 |
Device Lot Number | 17098639L |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/24/2015 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 01/06/2015 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 09/25/2014 |
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 |
|
|