MAUDE manufacturer profile
COVIDIEN LP LLC NORTH HAVEN · OCW
MAUDE profile for Endoscopic Tissue Approximation Device
Key facts
| Manufacturer | COVIDIEN LP LLC NORTH HAVEN |
|---|---|
| Manufacturer group | COVIDIEN LP LLC NORTH HAVEN |
| Product code | OCW |
| Product code name | Endoscopic Tissue Approximation Device |
At a glance
- 100–999 MAUDE reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Detachment of Device or Device Component, Detachment Of Device Component, Break, Human-Device Interface Problem, No Clinical Signs, Symptoms or Conditions, Component or Accessory Incompatibility, Foreign Body In Patient 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