MAUDE manufacturer profile
DENTSPLY LLC · FXX
MAUDE profile for Mask, Surgical
Key facts
| Manufacturer | DENTSPLY LLC |
|---|---|
| Manufacturer group | DENTSPLY LLC |
| Product code | FXX |
| Product code name | Mask, Surgical |
At a glance
- 10–99 MAUDE reports
- 10–99 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Hypersensitivity/Allergic reaction, Patient-Device Incompatibility, Adverse Event Without Identified Device or Use Problem, Rash, Skin Irritation, Itching Sensation, Erythema, Reaction 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