MAUDE manufacturer profile
ARJOHUNTLEIGH POLSKA SP. Z O.O. · IKY
MAUDE profile for Mattress, Flotation Therapy, Non-Powered
Key facts
| Manufacturer | ARJOHUNTLEIGH POLSKA SP. Z O.O. |
|---|---|
| Manufacturer group | ARJOHUNTLEIGH POLSKA SP. Z O.O. |
| Product code | IKY |
| Product code name | Mattress, Flotation Therapy, Non-Powered |
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
- Fall, Increase in Pressure, Adverse Event Without Identified Device or Use Problem, Pressure Sores, No Consequences Or Impact To Patient, Use of Device Problem, Insufficient Information, Decrease in Pressure 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