MAUDE manufacturer profile
OWEN MUMFORD LIMITED · FMI
MAUDE profile for Needle, Hypodermic, Single Lumen
Key facts
| Manufacturer | OWEN MUMFORD LIMITED |
|---|---|
| Manufacturer group | OWEN MUMFORD SDN BHD |
| Product code | FMI |
| Product code name | Needle, Hypodermic, Single Lumen |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Foreign Body In Patient, Separation Problem, Detachment of Device or Device Component, Anxiety, Discomfort, Distress, Needle Stick/Puncture, Material Twisted/Bent 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