MAUDE brand profile

OPTIPAC SOFTPAC REFOBACIN REVISION 40

MAUDE brand safety profile

Key facts

Brand name OPTIPAC SOFTPAC REFOBACIN REVISION 40

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
  • No Information, No Flow, Loosening of Implant Not Related to Bone-Ingrowth, Improper Chemical Reaction, Pain, Failure of Implant, Infusion or Flow Problem 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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