MAUDE manufacturer profile
KULZER GMBH - HQ · EBI
MAUDE profile for Resin, Denture, Relining, Repairing, Rebasing
Key facts
| Manufacturer | KULZER GMBH - HQ |
|---|---|
| Manufacturer group | KULZER GMBH - WEHRHEIM |
| Product code | EBI |
| Product code name | Resin, Denture, Relining, Repairing, Rebasing |
At a glance
- 10–99 MAUDE reports
- 10–99 Injury reports
- 10–99 Problems flagged by Orca1 signal analytics
- Hypersensitivity/Allergic reaction, Adverse Event Without Identified Device or Use Problem, Improper or Incorrect Procedure or Method, Use of Device Problem, Burning Sensation, Skin Inflammation/ Irritation, Local Reaction, Localized Skin Lesion 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