MAUDE manufacturer profile
BIOSENSE WEBSTER, INC. (IRWINDALE) · DQK
MAUDE profile for Computer, Diagnostic, Programmable
Key facts
| Manufacturer | BIOSENSE WEBSTER, INC. (IRWINDALE) |
|---|---|
| Manufacturer group | BIOSENSE WEBSTER, INC. (IRWINDALE) |
| Product code | DQK |
| Product code name | Computer, Diagnostic, Programmable |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, No Display/Image, Over-Sensing, Unexpected Therapeutic Results, Insufficient Information, Adverse Event Without Identified Device or Use Problem, Skin Tears, Atrial Fibrillation 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