MAUDE manufacturer profile
COVIDIEN · FCM
MAUDE profile for Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Key facts
| Manufacturer | COVIDIEN |
|---|---|
| Manufacturer group | COVIDIEN |
| Product code | FCM |
| Product code name | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Deflation Problem, No Consequences Or Impact To Patient, Detachment of Device or Device Component, No Known Impact Or Consequence To Patient, No Clinical Signs, Symptoms or Conditions, Foreign Body In Patient, Leak/Splash, Physical Resistance/Sticking 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