MAUDE manufacturer profile
MERIT MEDICAL SYSTEMS INC. · ODE
MAUDE profile for Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
Key facts
| Manufacturer | MERIT MEDICAL SYSTEMS INC. |
|---|---|
| Manufacturer group | MERIT MEDICAL SYSTEMS INC. |
| Product code | ODE |
| Product code name | Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd) |
At a glance
- 10–99 MAUDE reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Adverse Event Without Identified Device or Use Problem, Perforation of Esophagus, Mechanical Problem, Difficult to Insert, Pain, No Apparent Adverse Event, Material Separation 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