MAUDE manufacturer profile

ASPEN SURGICAL PRODUCTS, CALEDONIA · GAB

MAUDE profile for Needle, Suturing, Disposable

Key facts

Manufacturer ASPEN SURGICAL PRODUCTS, CALEDONIA
Manufacturer group SAME AS ABOVE
Product code GAB
Product code name Needle, Suturing, Disposable

At a glance

  • 10–99 MAUDE reports
  • 10–99 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Break, No Known Impact Or Consequence To Patient, Foreign Body In Patient, No Clinical Signs, Symptoms or Conditions, No Information, Device Or Device Fragments Location Unknown, Device Embedded In Tissue or Plaque, Material Separation 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

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