MAUDE manufacturer profile
COCHLEAR LIMITED · MHE
MAUDE profile for Implant, Auditory Brainstem
Key facts
| Manufacturer | COCHLEAR LIMITED |
|---|---|
| Manufacturer group | COCHLEAR LTD |
| Product code | MHE |
| Product code name | Implant, Auditory Brainstem |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Appropriate Term/Code Not Available, Hearing Impairment, Adverse Event Without Identified Device or Use Problem, No Code Available, Appropriate Term / Code Not Available, No Device Output, No Clinical Signs, Symptoms or Conditions, Unspecified Infection 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