MAUDE manufacturer profile
OVESCO ENDOSCOPY AG · PKL
MAUDE profile for Hemostatic Metal Clip For The Gi Tract
Key facts
| Manufacturer | OVESCO ENDOSCOPY AG |
|---|---|
| Manufacturer group | OVESCO ENDOSCOPY AG |
| Product code | PKL |
| Product code name | Hemostatic Metal Clip For The Gi Tract |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Use of Device Problem, Bowel Perforation, Adverse Event Without Identified Device or Use Problem, Insufficient Information, Improper or Incorrect Procedure or Method, Internal Organ Perforation, Perforation, Appropriate Term / Code Not Available 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