Brand Name | LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) |
Manufacturer (Section D) |
ALLERGAN |
la aurora de heredia |
CS |
|
Manufacturer (Section G) |
COSTA RICA |
900 pkwy global park zona franca |
|
la aurora de heredia |
CS
|
|
Manufacturer Contact |
karen
herrera
|
71 s. los carneros rd. |
goleta, CA 93117
|
8059615405
|
|
MDR Report Key | 3610801 |
MDR Text Key | 21052932 |
Report Number | 2024601-2013-01072 |
Device Sequence Number | 1 |
Product Code |
LTI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P000008 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Health Professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
11/14/2013 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 12/03/2010 |
Device Catalogue Number | B-2240 |
Device Lot Number | 1689422 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/14/2013
|
Initial Date FDA Received | 01/16/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/01/2008 |
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 Outcome(s) |
Required Intervention;
|