MAUDE manufacturer profile
MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH · MCM
MAUDE profile for Implant, Cochlear
Key facts
| Manufacturer | MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH |
|---|---|
| Product code | MCM |
| Product code name | Implant, Cochlear |
At a glance
- 1,000+ MAUDE reports
- 1–9 Death reports
- 1,000+ Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Failure of Implant, Output Problem, Device Operates Differently Than Expected, Impedance Problem, No Clinical Signs, Symptoms or Conditions, Adverse Event Without Identified Device or Use Problem, Migration, No Known Impact Or Consequence To Patient 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