MAUDE manufacturer profile
ASPEN SURGICAL PRODUCTS, CALEDONIA · FZZ
MAUDE profile for Marker, Skin
Key facts
| Manufacturer | ASPEN SURGICAL PRODUCTS, CALEDONIA |
|---|---|
| Manufacturer group | SAME AS ABOVE |
| Product code | FZZ |
| Product code name | Marker, Skin |
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, Unsealed Device Packaging, No Clinical Signs, Symptoms or Conditions, No Patient Involvement, Defective Component, Defective Device, Packaging Problem, Device Packaging Compromised 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