MAUDE brand profile

10ML 09 NACL INJECT USP PFS

MAUDE brand safety profile

Key facts

Brand name 10ML 09 NACL INJECT USP PFS

At a glance

  • 1–9 MAUDE reports
  • 1–9 Injury reports
  • 1–9 Malfunction reports
  • 1–9 Problems coded
  • 1–9 Problems flagged by Orca1 signal analytics
  • Fail-Safe Did Not Operate, Material Protrusion/Extrusion, Entrapment of Device, Positioning Failure, Material Separation, Device Dislodged or Dislocated, Device Embedded In Tissue or Plaque, Hemorrhage/Blood Loss/Bleeding Most reported problems

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About MAUDE brand safety profiles

Brand profiles aggregate every MAUDE report that names the brand, so you can compare report volumes and problem patterns across devices. Reports are unverified and do not by themselves establish causation.

Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1

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