MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-19 for ORBERA APOLLO B-EL0005 manufactured by Appollo Endosurgery Costa Rica S.r.l..
[180620350]
Gastric perforation due to gastric balloon. A (b)(6) y/o female presented to the ed a week after gastric balloon placement, found to have gastric perforation. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093139 |
| MDR Report Key | 9733695 |
| Date Received | 2020-02-19 |
| Date of Report | 2020-02-15 |
| Date of Event | 2020-02-04 |
| Date Added to Maude | 2020-02-20 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORBERA |
| Generic Name | IMIPLANT, INTRAGASTRIC FOR MORBID |
| Product Code | LTI |
| Date Received | 2020-02-19 |
| Model Number | APOLLO B-EL0005 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APPOLLO ENDOSURGERY COSTA RICA S.R.L. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention; 4. Deathisabilit | 2020-02-19 |