MAUDE manufacturer profile
ESTABLISHMENT LABS S.A. · MRD
MAUDE profile for Mammary Sizer
Key facts
| Manufacturer | ESTABLISHMENT LABS S.A. |
|---|---|
| Manufacturer group | ESTABLISHMENT LABS S.A. |
| Product code | MRD |
| Product code name | Mammary Sizer |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 1–9 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Gastritis, Rash, Fatigue, Dyspnea, Pain, Insufficient Information 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