Sonata® Case Kit CSKIT-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10817929020005), received between Dec 13, 2020 and Dec 13, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 13, 2020Improper or Incorrect Procedure or Method

  ON NOVEMBER 14, 2020 A DOCTOR REPORTED THAT A PATIENT HAD EXPERIENCED POTENTIAL SKIN BURNS AFTER USE OF THE SONATA SYSTEM. AFTER REMOVAL OF THE DISPERSIVE ELECTRODES (DE), THE DOCTOR OBSERVED THAT THE PATIENT'S SKIN ON ONE LEG, AT THE EDGE OF THE DE APPLICATION LOCATION, APPEARED TO BE VERY WARM AND RED. THE PHYSICIAN STATED THAT HOSPITAL STAFF SOMETIMES CLEANED THE PATIENT'S SKIN BEFORE PLACING THE DISPERSIVE ELECTRODES. THE DOCTOR REPORTED THAT IT IS UNKNOWN IF THE DISPERSIVE ELECTRODES WERE WET OR PLACED CORRECTLY BY THE HOSPITAL STAFF. THE EVENT OCCURRED ON (B)(6) 2019. ON NOV 18, 2020 THE DOCTOR REPORTED THAT THE BURN WOUND WAS A SECOND-DEGREE BURN AND WAS NOTED AFTER REMOVAL OF ONE OF THE DISPERSIVE ELECTRODES. THE PATIENT WAS TREATED WITH TOPICAL OINTMENT LALUGEN PLUS CREME (HYLARONIC ACID, SULFADIAZINE SILVER) AND RECOVERED UNEVENTFULLY. ON DEC 3, 2020, IT WAS NOTED THAT AN ELECTRICAL BLANKET WAS USED TO WARM THE PATIENT DURING THE PROCEDURE.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 10998594 ↗