MAUDE manufacturer profile
GENTHERM MEDICAL, LLC · DWJ
MAUDE profile for System, Thermal Regulating
Key facts
| Manufacturer | GENTHERM MEDICAL, LLC |
|---|---|
| Manufacturer group | GENTHERM MEDICAL, LLC |
| Product code | DWJ |
| Product code name | System, Thermal Regulating |
At a glance
- 10–99 MAUDE reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Burn(s), Adverse Event Without Identified Device or Use Problem, Insufficient Information, Use of Device Problem, Tissue Breakdown, Therapeutic or Diagnostic Output Failure, Overheating of Device 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