MAUDE manufacturer profile
ASPEN SURGICAL PRODUCTS, CALEDONIA · GCY
MAUDE profile for Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Key facts
| Manufacturer | ASPEN SURGICAL PRODUCTS, CALEDONIA |
|---|---|
| Manufacturer group | SAME AS ABOVE |
| Product code | GCY |
| Product code name | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Therapeutic or Diagnostic Output Failure, Break, Unsealed Device Packaging, Insufficient Information, No Clinical Signs, Symptoms or Conditions, Foreign Body In Patient, Device Operates Differently Than Expected 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