MAUDE manufacturer profile
UNOMEDICAL SDN BHD · EZL
MAUDE profile for Catheter, Retention Type, Balloon
Key facts
| Manufacturer | UNOMEDICAL SDN BHD |
|---|---|
| Manufacturer group | CONVATEC |
| Product code | EZL |
| Product code name | Catheter, Retention Type, Balloon |
At a glance
- 100–999 MAUDE reports
- 10–99 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, No Patient Involvement, Deflation Problem, Burst Container or Vessel, Material Deformation, Defective Device, Bent, Inflation Problem 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