MAUDE manufacturer profile
TEM INNOVATIONS GMBH · JPA
MAUDE profile for System, Multipurpose For In Vitro Coagulation Studies
Key facts
| Manufacturer | TEM INNOVATIONS GMBH |
|---|---|
| Manufacturer group | TEM INNOVATIONS GMBH |
| Product code | JPA |
| Product code name | System, Multipurpose For In Vitro Coagulation Studies |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Hematoma, Blood Loss, Hemorrhage/Blood Loss/Bleeding, Inadequate or Insufficient Training, Inadequate Instructions for Healthcare Professional, Data Problem, No Clinical Signs, Symptoms or Conditions 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