MAUDE manufacturer profile
HOLOGIC, INC · KGI
MAUDE profile for Densitometer, Bone
Key facts
| Manufacturer | HOLOGIC, INC |
|---|---|
| Manufacturer group | HOLOGIC, INC |
| Product code | KGI |
| Product code name | Densitometer, Bone |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Not Applicable, Device Displays Incorrect Message, Poor Quality Image, No Clinical Signs, Symptoms or Conditions, Device Stops Intermittently, Insufficient Information, No Known Impact Or Consequence To Patient, Unintended Electrical Shock 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