MAUDE manufacturer profile
DEXCOM, INC. · SAF
MAUDE profile for Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter
Key facts
| Manufacturer | DEXCOM, INC. |
|---|---|
| Manufacturer group | DEXCOM, INC. |
| Product code | SAF |
| Product code name | Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter |
At a glance
- 1,000+ MAUDE reports
- 10–99 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Detachment of Device or Device Component, Break, Foreign Body In Patient, Appropriate Term/Code Not Available, Pain, Erythema, Adverse Event Without Identified Device or Use Problem 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