MAUDE manufacturer profile
LIFESCAN EUROPE GMBH · FMK
MAUDE profile for Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Key facts
| Manufacturer | LIFESCAN EUROPE GMBH |
|---|---|
| Manufacturer group | LIFESCAN SCOTLAND |
| 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
- Defective Component, Appropriate Term/Code Not Available, Hypoglycemia, Shaking/Tremors, Sweating, Fatigue, Dizziness, Headache 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