MAUDE manufacturer profile
EDWARDS LIFESCIENCES · DXZ
MAUDE profile for Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Key facts
| Manufacturer | EDWARDS LIFESCIENCES |
|---|---|
| Manufacturer group | EDWARDS LIFESCIENCES |
| Product code | DXZ |
| Product code name | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
At a glance
- 100–999 MAUDE reports
- 100–999 Death reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, No Clinical Signs, Symptoms or Conditions, Fluid/Blood Leak, No Patient Involvement, No Information, Packaging Problem, Appropriate Term/Code Not Available, Tear, Rip or Hole in Device Packaging 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