MAUDE manufacturer profile
AMBU A/S · IKT
MAUDE profile for Electrode, Needle, Diagnostic Electromyograph
Key facts
| Manufacturer | AMBU A/S |
|---|---|
| Manufacturer group | AMBU SDN.BHD |
| Product code | IKT |
| Product code name | Electrode, Needle, Diagnostic Electromyograph |
At a glance
- 10–99 MAUDE reports
- 10–99 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Break, Foreign Body In Patient, Device Embedded In Tissue or Plaque, Detachment of Device or Device Component, Entrapment of Device, Mechanical Problem, Needle Stick/Puncture, Patient Problem/Medical Problem 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