MAUDE manufacturer profile
ONSET MEDICAL CORPORATION · DYB
MAUDE profile for Introducer, Catheter
Key facts
| Manufacturer | ONSET MEDICAL CORPORATION |
|---|---|
| Manufacturer group | ONSET MEDICAL CORPORATION |
| Product code | DYB |
| Product code name | Introducer, Catheter |
At a glance
- 10–99 MAUDE reports
- 10–99 Death reports
- 10–99 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Consequences Or Impact To Patient, Difficult to Remove, Blood Loss, Break, No Known Impact Or Consequence To Patient, Device Embedded In Tissue or Plaque, Death, Entrapment of Device 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