MAUDE manufacturer profile
GETINGE IC PRODUCTION POLAND SP. Z.O.O. · FLE
MAUDE profile for Sterilizer, Steam
Key facts
| Manufacturer | GETINGE IC PRODUCTION POLAND SP. Z.O.O. |
|---|---|
| Manufacturer group | GETINGE IC PRODUCTION POLAND SP. Z.O.O. |
| Product code | FLE |
| Product code name | Sterilizer, Steam |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Leak/Splash, No Consequences Or Impact To Patient, No Known Impact Or Consequence To Patient, No Clinical Signs, Symptoms or Conditions, Unintended Movement, Device Fell, Sharp Edges, Device Handling Problem 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