MAUDE manufacturer profile
MONICA HEALTHCARE LTD · OSP
MAUDE profile for Uterine Electromyographic Monitor
Key facts
| Manufacturer | MONICA HEALTHCARE LTD |
|---|---|
| Manufacturer group | MONICA HEALTHCARE LTD |
| Product code | OSP |
| Product code name | Uterine Electromyographic Monitor |
At a glance
- 1–9 MAUDE reports
- 1–9 Death reports
- 1–9 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Patient Data Problem, Defective Alarm, Device Sensing Problem, Appropriate Term/Code Not Available, Insufficient Information, Adverse Event Without Identified Device or Use Problem, Diminished Pulse Pressure, Superficial (First Degree) Burn 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