MAUDE manufacturer profile
PENTAX OF AMERICAS, INC. · GEH
MAUDE profile for Unit, Cryosurgical, Accessories
Key facts
| Manufacturer | PENTAX OF AMERICAS, INC. |
|---|---|
| Manufacturer group | PENTAX OF AMERICAS, INC. |
| 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
- Perforation of Esophagus, Premature Activation, Unintended Movement, Adverse Event Without Identified Device or Use Problem, Firing Problem, Pain, No Clinical Signs, Symptoms or Conditions, Laceration(s) of Esophagus 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