MAUDE brand profile
ONESTEP COMPLETE SINGLE R SERIES
MAUDE brand safety profile
Key facts
| Brand name | ONESTEP COMPLETE SINGLE R SERIES |
|---|
At a glance
- 1–9 MAUDE reports
- 1–9 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems coded
- 1–9 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Failure of Device to Self-Test, Loss of or Failure to Bond, Device Dislodged or Dislocated, Incorrect, Inadequate or Imprecise Result or Readings, Adverse Event Without Identified Device or Use Problem, Failure to Charge, Partial thickness (Second Degree) Burn 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