MAUDE manufacturer profile
HOLOGIC, INC · HIH
MAUDE profile for Hysteroscope (And Accessories)
Key facts
| Manufacturer | HOLOGIC, INC |
|---|---|
| Manufacturer group | HOLOGIC, INC. |
| Product code | HIH |
| Product code name | Hysteroscope (And Accessories) |
At a glance
- 100–999 MAUDE reports
- 10–99 Death reports
- 100–999 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Uterine Perforation, No Clinical Signs, Symptoms or Conditions, Foreign Body In Patient, Insufficient Information, Hemorrhage/Blood Loss/Bleeding, Bowel Perforation, 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