MAUDE manufacturer profile
DEGANIA SILICONE LTD · OTK
MAUDE profile for Wound Drain Catheter System
Key facts
| Manufacturer | DEGANIA SILICONE LTD |
|---|---|
| Manufacturer group | DEGANIA SILICONE LTD |
| Product code | OTK |
| Product code name | Wound Drain Catheter System |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Material Rupture, No Clinical Signs, Symptoms or Conditions, No Consequences Or Impact To Patient, Device Embedded In Tissue or Plaque, Adverse Event Without Identified Device or Use Problem, Foreign Body In Patient, Hemorrhage/Blood Loss/Bleeding, No Information 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