MAUDE manufacturer profile
MALLINCKRODT MANUFACTURING LLC · MRN
MAUDE profile for Apparatus, Nitric Oxide Delivery
Key facts
| Manufacturer | MALLINCKRODT MANUFACTURING LLC |
|---|---|
| Manufacturer group | MALLINCKRODT MANUFACTURING LLC |
| Product code | MRN |
| Product code name | Apparatus, Nitric Oxide Delivery |
At a glance
- 1,000+ MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, No Known Impact Or Consequence To Patient, Failure to Deliver, High Readings, Failure to Recalibrate, Intermittent Communication Failure, Device Displays Incorrect Message, Inaccurate Delivery 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