MAUDE manufacturer profile
GALT MEDICAL CORP. · OFL
MAUDE profile for Percutaneous Sheath Introducer Kit
Key facts
| Manufacturer | GALT MEDICAL CORP. |
|---|---|
| Manufacturer group | GALT MEDICAL CORP |
| Product code | OFL |
| Product code name | Percutaneous Sheath Introducer Kit |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Break, Foreign Body In Patient, Physical Resistance/Sticking, No Clinical Signs, Symptoms or Conditions, Material Integrity Problem, Material Frayed, Hemorrhage/Blood Loss/Bleeding, Pain 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