MAUDE manufacturer profile
INTEGRA LIFESCIENCES (IRELAND) LTD. · FSR
MAUDE profile for Light, Headband, Surgical
Key facts
| Manufacturer | INTEGRA LIFESCIENCES (IRELAND) LTD. |
|---|---|
| Manufacturer group | INTEGRA LIFESCIENCES (IRELAND) LTD. |
| Product code | FSR |
| Product code name | Light, Headband, Surgical |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Overheating of Device, Electrical Shorting, Intermittent Energy Output, Adverse Event Without Identified Device or Use Problem, Headache, Intermittent Loss of Power, Insufficient Heating 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