MAUDE manufacturer profile
UNOMEDICAL SDN BHD · BTR
MAUDE profile for Tube, Tracheal (W/Wo Connector)
Key facts
| Manufacturer | UNOMEDICAL SDN BHD |
|---|---|
| Manufacturer group | CONVATEC |
| Product code | BTR |
| Product code name | Tube, Tracheal (W/Wo Connector) |
At a glance
- 1,000+ MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Patient Involvement, Device Contamination with Chemical or Other Material, No Known Impact Or Consequence To Patient, Inflation Problem, Leak/Splash, Device Packaging Compromised, Device Markings/Labelling Problem, Air Leak 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