MAUDE manufacturer profile
ERIKA DE REYNOSA, S.A. DE C.V. · KDI
MAUDE profile for Dialyzer, High Permeability With Or Without Sealed Dialysate System
Key facts
| Manufacturer | ERIKA DE REYNOSA, S.A. DE C.V. |
|---|---|
| Manufacturer group | ERIKA DE REYNOSA, S.A. DE C.V. |
| Product code | KDI |
| Product code name | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Fluid/Blood Leak, No Clinical Signs, Symptoms or Conditions, Hemorrhage/Blood Loss/Bleeding, Thermal Decomposition of Device, No Known Impact Or Consequence To Patient, Adverse Event Without Identified Device or Use Problem, Inadequate Ultra Filtration, Cardiac Arrest 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