MAUDE manufacturer profile
SHOCKWAVE MEDICAL, INC. · QMG
MAUDE profile for Shockwave Intravascular Lithotripsy System
Key facts
| Manufacturer | SHOCKWAVE MEDICAL, INC. |
|---|---|
| Manufacturer group | SHOCKWAVE MEDICAL, INC. |
| Product code | QMG |
| Product code name | Shockwave Intravascular Lithotripsy System |
At a glance
- 100–999 MAUDE reports
- 10–99 Death reports
- 100–999 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Myocardial Infarction, No Clinical Signs, Symptoms or Conditions, Vascular Dissection, Cardiac Arrest, Perforation of Vessels, Material Split, Cut or Torn, Chest Pain 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