MAUDE manufacturer profile
ASPEN SURGICAL PRODUCTS, CALEDONIA · FSM
MAUDE profile for Tray, Surgical, Instrument
Key facts
| Manufacturer | ASPEN SURGICAL PRODUCTS, CALEDONIA |
|---|---|
| Manufacturer group | SAME AS ABOVE |
| Product code | FSM |
| Product code name | Tray, Surgical, Instrument |
At a glance
- 10–99 MAUDE reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Tear, Rip or Hole in Device Packaging, No Patient Involvement, No Known Impact Or Consequence To Patient, No Information, Device Packaging Compromised, Unsealed Device Packaging, Packaging Problem, Hole In Material 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