MAUDE manufacturer profile
KULZER GMBH - HQ · ELW
MAUDE profile for Material, Impression
Key facts
| Manufacturer | KULZER GMBH - HQ |
|---|---|
| Manufacturer group | KULZER SRL |
| Product code | ELW |
| Product code name | Material, Impression |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 1–9 Problems flagged by Orca1 signal analytics
- Improper or Incorrect Procedure or Method, Use of Device Problem, No Clinical Signs, Symptoms or Conditions, Positioning Failure, Off-Label Use, Discomfort, Dyspnea 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