MAUDE manufacturer profile
MEDTRONIC PUERTO RICO OPERATIONS CO. · FRN
MAUDE profile for Pump, Infusion
Key facts
| Manufacturer | MEDTRONIC PUERTO RICO OPERATIONS CO. |
|---|---|
| Manufacturer group | MEDTRONIC PUERTO RICO OPERATIONS CO. |
| Product code | FRN |
| Product code name | Pump, Infusion |
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
- Hyperglycemia, Device Displays Incorrect Message, No Clinical Signs, Symptoms or Conditions, No Known Impact Or Consequence To Patient, Improper Flow or Infusion, Air Leak, Fluid/Blood Leak, No Consequences Or Impact To Patient 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