MAUDE manufacturer profile
ASCENSIA DIABETES CARE US INC. · FMK
MAUDE profile for Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Key facts
| Manufacturer | ASCENSIA DIABETES CARE US INC. |
|---|---|
| Manufacturer group | HTL-STREFA S.A. |
| Product code | FMK |
| Product code name | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature |
At a glance
- 10–99 MAUDE reports
- 10–99 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Needle Stick/Puncture, Improper or Incorrect Procedure or Method, Component Missing, Injury, Insufficient Information, No Clinical Signs, Symptoms or Conditions, Device Contamination with Body Fluid, Break 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