NA CC101020Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00813250012712), received between Mar 12, 2018 and May 9, 2018 — classified as 2 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT TWO WEEKS AFTER A RADIOFREQUENCY PROCEDURE THE PATIENT EXPERIENCED A REACTION THAT WERE INITIALLY ASSESSED TO BE BURN MARKS AT THE PUNCTURE SITE. THE SIZES OF THE MARKS WERE LESS THAN 1 CENTIMETER AND WERE LOCATED AT L3-S1. DURING THE PROCEDURE IT WAS NOTED THAT THE PHYSICIAN INJECTED 1-2 ML OF TRIGON 400 MG/ML WITH SALINE THROUGH THE CANNULAS. THEY DID NOT USE ANY SKIN PREPARATION OR DRESSING THAT COULD HAVE GOTTEN INTO THE PUNCTURE SITE. THE PHYSICIAN FELT THAT MARKS WERE RELATED TO USE OF THE CANNULA, AND LATER ASSESSED THAT HE DOESN¿T KNOW THE CAUSE OF THE REACTION BUT BELIEVE IT COULD BE AN ALLERGIC REACTION. THE PATIENT WAS ADMINISTERED A TWO MONTH PRESCRIPTION FOR CORTICOID OINTMENT THE PATIENT IS DOING FINE. THERE IS NO FURTHER COURSE OF ACTION.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 7499015 ↗
• InjuryMar 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT AFTER A RADIOFREQUENCY PROCEDURE THE PATIENT EXPERIENCED A REACTION THAT WERE INITIALLY ASSESSED TO BE BURN MARKS AT THE PUNCTURE SITE. DURING THE PROCEDURE IT WAS NOTED THAT THE PHYSICIAN INJECTED 1-2 ML OF TRIGON 400 MG/ML WITH SALINE THROUGH THE CANNULAS. THEY DID NOT USE ANY SKIN PREPARATION OR DRESSING THAT COULD HAVE GOTTEN INTO THE PUNCTURE SITE. THE PHYSICIAN FELT THAT MARKS WERE RELATED TO USE OF THE CANNULA, AND LATER ASSESSED THAT HE DOESN'T KNOW THE CAUSE OF THE REACTION BUT BELIEVE IT COULD BE AN ALLERGIC REACTION. THE PATIENT WAS ADMINISTERED A PRESCRIPTION FOR CORTICOID AND THE PATIENT IS DOING FINE. THERE IS NO FURTHER COURSE OF ACTION.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 7332979 ↗