MAUDE manufacturer profile
ACUMED, LLC · KWI
MAUDE profile for Prosthesis, Elbow, Hemi-, Radial, Polymer
Key facts
| Manufacturer | ACUMED, LLC |
|---|---|
| Manufacturer group | ACUMED LLC |
| Product code | KWI |
| Product code name | Prosthesis, Elbow, Hemi-, Radial, Polymer |
At a glance
- 100–999 MAUDE reports
- 100–999 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Code Available, Adverse Event Without Identified Device or Use Problem, No Known Impact Or Consequence To Patient, Device Dislodged or Dislocated, Detachment Of Device Component, Material Separation, Appropriate Term/Code Not Available, Loss of Range of Motion 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