MAUDE manufacturer profile
COOK IRELAND LTD · MUM
MAUDE profile for Stent, Metallic, Expandable, Duodenal
Key facts
| Manufacturer | COOK IRELAND LTD |
|---|---|
| Manufacturer group | COOK IRELAND LTD |
| Product code | MUM |
| Product code name | Stent, Metallic, Expandable, Duodenal |
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
- No Known Impact Or Consequence To Patient, Adverse Event Without Identified Device or Use Problem, Activation, Positioning or Separation Problem, Obstruction/Occlusion, No Clinical Signs, Symptoms or Conditions, Break, No Consequences Or Impact To Patient, Delivery System Failure 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