MAUDE manufacturer profile
COVIDIEN MFG DC BOULDER · HGI
MAUDE profile for Electrocautery, Gynecologic (And Accessories)
Key facts
| Manufacturer | COVIDIEN MFG DC BOULDER |
|---|---|
| Manufacturer group | COVIDIEN MFG DC BOULDER |
| Product code | HGI |
| Product code name | Electrocautery, Gynecologic (And Accessories) |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Melted, No Clinical Signs, Symptoms or Conditions, Peeled/Delaminated, Detachment of Device or Device Component, No Consequences Or Impact To Patient, Adverse Event Without Identified Device or Use Problem, Break, Burn(s) 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