MAUDE manufacturer profile
INTEGRA LIFESCIENCES CORPORATION · FRO
MAUDE profile for Dressing, Wound, Drug
Key facts
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION |
|---|---|
| Manufacturer group | INTEGRA LIFESCIENCES CORPORATION |
| Product code | FRO |
| Product code name | Dressing, Wound, Drug |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, No Known Impact Or Consequence To Patient, Bacterial Infection, Insufficient Information, No Consequences Or Impact To Patient, Sepsis, Unspecified Infection, Shelf Life Exceeded 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