Brand Name | ORBERA INTRAGASTRIC BALLOON |
Type of Device | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY |
Manufacturer (Section D) |
ALLERGAN (COSTA RICA) |
900 parkway global park |
zona franca |
|
CS |
|
Manufacturer (Section G) |
ALLERGAN (COSTA RICA) |
900 parkway global park |
zona franca |
|
CS
|
|
Manufacturer Contact |
laura
leboeuf
|
1120 s capital of texas hwy |
building 1, suite 300 |
austin, TX 78748
|
8555513123
|
|
MDR Report Key | 5207225 |
MDR Text Key | 30587316 |
Report Number | 3006722112-2015-00536 |
Device Sequence Number | 1 |
Product Code |
LTI
|
Combination Product (y/n) | N |
Reporter Country Code | BR |
PMA/PMN Number | P140008 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
10/19/2015 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 09/16/2015 |
Device Catalogue Number | B-50000 |
Device Lot Number | 2499828 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/19/2015
|
Initial Date FDA Received | 11/06/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/16/2013 |
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 |
Treatment | NONE PER PHYSICIAN |
Patient Outcome(s) |
Other;
Required Intervention;
|
Patient Age | 40 YR |
Patient Weight | 66 |