MAUDE manufacturer profile
HOLOGIC, INC · OTE
MAUDE profile for Digital Breast Tomosynthesis
Key facts
| Manufacturer | HOLOGIC, INC |
|---|---|
| Manufacturer group | HOLOGIC, INC |
| Product code | OTE |
| Product code name | Digital Breast Tomosynthesis |
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, No Clinical Signs, Symptoms or Conditions, Not Applicable, No Consequences Or Impact To Patient, Poor Quality Image, Device Operates Differently Than Expected, Device Displays Incorrect Message, 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