MAUDE manufacturer profile
MERIT MEDICAL SYSTEMS INC. · OEQ
MAUDE profile for Angiography/Angioplasty Kit
Key facts
| Manufacturer | MERIT MEDICAL SYSTEMS INC. |
|---|---|
| Manufacturer group | MERIT MEDICAL SYSTEMS INC. |
| Product code | OEQ |
| Product code name | Angiography/Angioplasty Kit |
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
- No Clinical Signs, Symptoms or Conditions, Unsealed Device Packaging, Tear, Rip or Hole in Device Packaging, No Apparent Adverse Event, Manufacturing, Packaging or Shipping Problem, Packaging Problem, No Patient Involvement, Material Separation 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