MAUDE brand profile

SPECTRIS SOLARIS SYRINGE KIT

MAUDE brand safety profile

Key facts

Brand name SPECTRIS SOLARIS SYRINGE KIT

At a glance

  • 10–99 MAUDE reports
  • 1–9 Death reports
  • 1–9 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems coded
  • 10–99 Problems flagged by Orca1 signal analytics
  • Manufacturing, Packaging or Shipping Problem, No Patient Involvement, No Clinical Signs, Symptoms or Conditions, Device Contamination with Chemical or Other Material, No Known Impact Or Consequence To Patient, Contamination /Decontamination Problem, Break, No Information 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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