MAUDE manufacturer profile
ERIKA DE REYNOSA, S.A. DE C.V. · FKX
MAUDE profile for System, Peritoneal, Automatic Delivery
Key facts
| Manufacturer | ERIKA DE REYNOSA, S.A. DE C.V. |
|---|---|
| Manufacturer group | ERIKA DE REYNOSA, S.A. DE C.V. |
| Product code | FKX |
| Product code name | System, Peritoneal, Automatic Delivery |
At a glance
- 1,000+ MAUDE reports
- 100–999 Death reports
- 1,000+ Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Fluid/Blood Leak, Adverse Event Without Identified Device or Use Problem, No Known Impact Or Consequence To Patient, Peritonitis, No Clinical Signs, Symptoms or Conditions, Abdominal Pain, Thermal Decomposition of Device, Unspecified Infection 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