MAUDE brand profile
ONETOUCH ULTRA TEST STRIPS
MAUDE brand safety profile
Key facts
| Brand name | ONETOUCH ULTRA TEST STRIPS |
|---|
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems coded
- 10–99 Problems flagged by Orca1 signal analytics
- No Consequences Or Impact To Patient, Loss of consciousness, Incorrect, Inadequate or Imprecise Result or Readings, Insufficient Information, Device Markings/Labelling Problem, Convulsion/Seizure, Material Twisted/Bent, Unsealed Device Packaging 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