MAUDE manufacturer profile
PENTAX MEDICAL · GEH
MAUDE profile for Unit, Cryosurgical, Accessories
Key facts
| Manufacturer | PENTAX MEDICAL |
|---|---|
| Manufacturer group | PENTAX OF AMERICAS, INC. (C2) |
| Product code | GEH |
| Product code name | Unit, Cryosurgical, Accessories |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 1–9 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- Laceration(s), Adverse Event Without Identified Device or Use Problem, Failure to Deflate, Perforation, Abdominal Pain, Unspecified Tissue Injury, 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