MAUDE manufacturer profile
GENTHERM MEDICAL, LLC · ILO
MAUDE profile for Pack, Hot Or Cold, Water Circulating
Key facts
| Manufacturer | GENTHERM MEDICAL, LLC |
|---|---|
| Manufacturer group | GENTHERM MEDICAL, LLC |
| Product code | ILO |
| Product code name | Pack, Hot Or Cold, Water Circulating |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Fluid/Blood Leak, No Clinical Signs, Symptoms or Conditions, Incorrect, Inadequate or Imprecise Result or Readings, Adverse Event Without Identified Device or Use Problem, Alteration in Body Temperature, Muscle/Tendon Damage, Tissue Breakdown, Laceration(s) 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