MAUDE manufacturer profile
HISTOSONICS, INC. · QGM
MAUDE profile for Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation
Key facts
| Manufacturer | HISTOSONICS, INC. |
|---|---|
| Manufacturer group | HISTOSONICS, INC |
| Product code | QGM |
| Product code name | Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Renal Impairment, Hemorrhage/Blood Loss/Bleeding, Renal Failure, Pseudoaneurysm, Abdominal Pain, Low Blood Pressure/ Hypotension, Gastrointestinal Hemorrhage 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