MAUDE manufacturer profile
TSCI BV DBA THE 37COMPANY · DWJ
MAUDE profile for System, Thermal Regulating
Key facts
| Manufacturer | TSCI BV DBA THE 37COMPANY |
|---|---|
| Manufacturer group | TSCI BV DBA THE 37COMPANY |
| Product code | DWJ |
| Product code name | System, Thermal Regulating |
At a glance
- 10–99 MAUDE reports
- 1–9 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, Electrical /Electronic Property Problem, Burn(s), Patient Device Interaction Problem, Skin Tears, Excessive Heating, Device Operates Differently Than Expected 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