Brand Name | ORBERA365 INTRAGASTRIC BALLOON SYSTEM |
Type of Device | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY |
Manufacturer (Section D) |
APOLLO ENDOSURGERY |
1120 s capital of texas hwy |
bldg 1 suite 300 |
austin TX 78746 |
|
Manufacturer (Section G) |
APOLLO ENDOSURGERY COSTA RICA S.R.L |
|
|
alajuela, 02 |
CS
|
|
Manufacturer Contact |
carole
morley
|
300 boston scientific way |
marlborough, MA 01752
|
5086834015
|
|
MDR Report Key | 18290609 |
MDR Text Key | 330041389 |
Report Number | 3005099803-2023-06590 |
Device Sequence Number | 1 |
Product Code |
LTI
|
Combination Product (y/n) | N |
Reporter Country Code | PL |
PMA/PMN Number | P140008 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
12/08/2023 |
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 Model Number | AF05105 |
Device Lot Number | AF05105 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/14/2023
|
Initial Date FDA Received | 12/08/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/13/2022 |
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;
|
Patient Age | 45 YR |
Patient Sex | Female |
Patient Weight | 75 KG |