MAUDE manufacturer profile
STERIS MEXICO, S. DE R.L. DE C.V. · FLE
MAUDE profile for Sterilizer, Steam
Key facts
| Manufacturer | STERIS MEXICO, S. DE R.L. DE C.V. |
|---|---|
| Manufacturer group | STERIS MEXICO, S. DE R.L. DE C.V. |
| Product code | FLE |
| Product code name | Sterilizer, Steam |
At a glance
- 100–999 MAUDE reports
- 10–99 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, No Clinical Signs, Symptoms or Conditions, Leak/Splash, Fluid/Blood Leak, Adverse Event Without Identified Device or Use Problem, Device Fell, Injury, 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