MAUDE manufacturer profile
ENDOGASTRIC SOLUTIONS, INC · ODE
MAUDE profile for Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
Key facts
| Manufacturer | ENDOGASTRIC SOLUTIONS, INC |
|---|---|
| Manufacturer group | ENDOGASTRIC SOLUTIONS, INC |
| Product code | ODE |
| Product code name | Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd) |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 100–999 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Perforation, Perforation of Esophagus, Insufficient Information, Pleural Effusion, No Clinical Signs, Symptoms or Conditions, Hemorrhage/Blood Loss/Bleeding, Laceration(s) of Esophagus Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE manufacturer and product code profiles
Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1