Freedom-4A Trial Kit Channel A US w/ Receiver FR4A-TRL-A0Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00818225020594), received between Nov 12, 2019 and Dec 11, 2019 — classified as 3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STIMWAVE QUALITY HAS INVESTIGATED THE DETAILS REGARDING A COMPLAINT RESULTING FROM AN INFECTION REPORTED TO STIMWAVE ON NOVEMBER 19, 2019, BY TERRITORY MANAGER.

  Patient problems: Unspecified Infection

  MAUDE report 9454452 ↗
• InjuryDec 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STIMWAVE QUALITY HAS INVESTIGATED THE DETAILS REGARDING A COMPLAINT RESULTING FROM AN INFECTION REPORTED TO STIMWAVE ON (B)(6) 2019, BY TERRITORY MANAGER.

  Patient problems: Bacterial Infection

  MAUDE report 9418645 ↗
• InjuryNov 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STIMWAVE QUALITY HAS INVESTIGATED THE DETAILS REGARDING A COMPLAINT RESULTING FROM AN INFECTION REPORTED TO STIMWAVE ON OCTOBER 23, 2019.

  Patient problems: Cellulitis

  MAUDE report 9312667 ↗