MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-11 for OBALON BALLOON SYSTEM 7600-0001 manufactured by Obalon Therapeutics, Inc..
| Report Number | 3009256831-2020-00001 |
| MDR Report Key | 9696626 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-11 |
| Date of Report | 2020-01-13 |
| Date of Event | 2020-01-11 |
| Date Mfgr Received | 2020-01-13 |
| Device Manufacturer Date | 2017-11-22 |
| Date Added to Maude | 2020-02-11 |
| 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 | MS. AMY VANDENBERG |
| Manufacturer Street | 5421 AVENDIA ENCINAS SUITE F |
| Manufacturer City | CARLSBAD, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 7956551 |
| Manufacturer G1 | OBALON THERAPEUTICS, INC. |
| Manufacturer Street | 5421 AVENIDA ENCINAS SUITE F |
| Manufacturer City | CARLSBAD, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OBALON BALLOON SYSTEM |
| Generic Name | INTRAGASTIC BALLOON |
| Product Code | LTI |
| Date Received | 2020-02-11 |
| Model Number | 7600-0001 |
| Lot Number | 171122406 |
| Device Expiration Date | 2018-11-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OBALON THERAPEUTICS, INC. |
| Manufacturer Address | 5421 AVENDIA ENCINAS SUITE F CARLSBAD, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-02-11 |