MAUDE brand profile
GLOOKO DEVICE SYSTEM
MAUDE brand safety profile
Key facts
| Brand name | GLOOKO DEVICE SYSTEM |
|---|
At a glance
- 10–99 MAUDE reports
- 10–99 Malfunction reports
- 10–99 Problems coded
- 10–99 Problems flagged by Orca1 signal analytics
- Patient Data Problem, No Known Impact Or Consequence To Patient, No Clinical Signs, Symptoms or Conditions, Computer Software Problem, Loss of Data, Device Markings/Labelling Problem, Data Problem, Improper or Incorrect Procedure or Method Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE brand safety profiles
Brand profiles aggregate every MAUDE report that names the brand, so you can compare report volumes and problem patterns across devices. Reports are unverified and do not by themselves establish causation.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1