MAUDE manufacturer profile
MEDELA AG · BTA
MAUDE profile for Pump, Portable, Aspiration (Manual Or Powered)
Key facts
| Manufacturer | MEDELA AG |
|---|---|
| Manufacturer group | MEDELA AG |
| Product code | BTA |
| Product code name | Pump, Portable, Aspiration (Manual Or Powered) |
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
- Adverse Event Without Identified Device or Use Problem, Gas/Air Leak, Hemothorax, Pneumothorax, Air Leak, No Clinical Signs, Symptoms or Conditions, Pulmonary Emphysema, Complete Blockage 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