MAUDE manufacturer profile
HOLOGIC INC · MUE
MAUDE profile for Full Field Digital, System, X-Ray, Mammographic
Key facts
| Manufacturer | HOLOGIC INC |
|---|---|
| Manufacturer group | HOLOGIC, INC |
| Product code | MUE |
| Product code name | Full Field Digital, System, X-Ray, Mammographic |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Unintended System Motion, Not Applicable, No Clinical Signs, Symptoms or Conditions, No Consequences Or Impact To Patient, Device Displays Incorrect Message, Poor Quality Image, Device Operates Differently Than Expected, 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