Brand Name | GEN2 ADJUSTABLE GASTRIC BAND - 11 CM, UNLOCKA |
Type of Device | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY |
Manufacturer (Section D) |
OBTECH MEDICAL SARL_ |
chemin-blanc 38 |
le locle CH-24 00 |
SZ CH-2400 |
|
Manufacturer (Section G) |
OBTECH MEDICAL SARL |
chemin-blanc 38 |
|
le locle CH-24 00 |
SZ
CH-2400
|
|
Manufacturer Contact |
guillermo
villa
|
route 22 west po box 151 |
somerville, NJ 08876
|
9082180707
|
|
MDR Report Key | 5680911 |
MDR Text Key | 46018230 |
Report Number | 3005992282-2016-00015 |
Device Sequence Number | 1 |
Product Code |
LTI
|
Combination Product (y/n) | N |
Reporter Country Code | SP |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup,Followup |
Report Date |
04/25/2016 |
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 | 02/28/2014 |
Device Catalogue Number | BD3XV |
Device Lot Number | 20148016 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
04/25/2016
|
Initial Date FDA Received | 05/25/2016 |
Supplement Dates Manufacturer Received | Not provided Not provided
|
Supplement Dates FDA Received | 05/31/2016 06/06/2016
|
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 01/22/2009 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |