MAUDE manufacturer profile

ASPEN SURGICAL PRODUCTS · GAB

MAUDE profile for Needle, Suturing, Disposable

Key facts

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

At a glance

  • 10–99 MAUDE reports
  • 1–9 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Break, No Clinical Signs, Symptoms or Conditions, No Known Impact Or Consequence To Patient, Foreign Body In Patient, Detachment of Device or Device Component, Insufficient Information, Packaging Problem, Device Embedded In Tissue or Plaque 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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