MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-17 for ORBERA 365 INTRAGASTRIC BALLOON SYSTEM B-50012 manufactured by Apollo Endosurgery, Inc..
| Report Number | 3006722112-2020-00039 |
| MDR Report Key | 9843809 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-17 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-02-19 |
| Date Mfgr Received | 2020-02-20 |
| Device Manufacturer Date | 2018-06-04 |
| Date Added to Maude | 2020-03-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR. DAVID HOOPER |
| Manufacturer Street | 1120 S. CAPITAL OF TEXAS HWY BLDG 1, STE. 300 |
| Manufacturer City | AUSTIN, TX |
| Manufacturer Country | US |
| Manufacturer G1 | APOLLO ENDOSURGERY COSTA RICA, SRL |
| Manufacturer Street | COYOL FREE ZONE BUILDING B 13.3 |
| Manufacturer City | ALAJUELA, CS |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORBERA 365 INTRAGASTRIC BALLOON SYSTEM |
| Generic Name | INTRAGASTRIC BALLOON |
| Product Code | LTI |
| Date Received | 2020-03-17 |
| Model Number | B-50012 |
| Catalog Number | B-50012 |
| Lot Number | AF01975 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APOLLO ENDOSURGERY, INC. |
| Manufacturer Address | 1120 S. CAPITAL OF TEXAS HWY BLDG 1, STE. 300 AUSTIN, TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-17 |