MAUDE manufacturer profile
COOK INC · FMI
MAUDE profile for Needle, Hypodermic, Single Lumen
Key facts
| Manufacturer | COOK INC |
|---|---|
| Manufacturer group | COOK INC |
| Product code | FMI |
| Product code name | Needle, Hypodermic, Single Lumen |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Break, Contamination /Decontamination Problem, Difficult to Insert, Material Separation, Material Twisted/Bent, Use of Device Problem, Device Dislodged or Dislocated 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