Sonata® Procedure Kit PROKIT-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10817929020166), received between Dec 13, 2020 and Dec 13, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (2 reports).

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.

• InjuryDec 13, 2020Material Separation; Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(6) 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) 2020. ON (B)(6) 2020, THE DOCTOR ALSO REPORTED THAT BASED ON THE INFORMATION PROVIDED, A CLEANING SOLUTION BENZIN MEDIZINAL (WOUND BENZIN) WAS USED TO CLEAN THE ANTERIOR THIGH OF THE PATIENT'S LEG PRIOR TO APPLICATION OF THE DISPERSIVE ELECTRODE. THE DOCTOR REPORTED THAT THE DISPERSIVE ELECTRODE ADHESIVE APPEARED TO HAVE PARTIALLY SEPARATED FROM THE ELECTRODE COVERING. THE DOCTOR REPORTED THAT THE BURN WAS A SECOND DEGREE BURN IN ONE LEG. THE PATIENT WAS MANAGED WITH TOPICAL THERAPY LALUGEN PLUS CRÈME (HYLARONIC ACID, SULFADIAZIN SILVER) AND RECOVERED UNEVENTFULLY. ON (B)(6) 2020, IT WAS NOTED THAT AN ELECTRICAL BLANKET WA

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 10998587 ↗
• InjuryDec 13, 2020Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Improper 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 DOCTOR INITIALLY REPORTED THAT THE PATIENT SUFFERED A 3RD-DEGREE BURN WITH NECROTIC CRUST FORMATION. A PLASTIC AND RECONSTRUCTIVE SURGEON WAS CONSULTED, AND THE WOUND WAS DEBRIDED. SKIN GRAFTING WAS ADVISED, BUT THE PATIENT DECLINED. THE PATIENT OPTED FOR LASER PHOTOSTIMULATION IN LIEU OF SKIN GRAFTING AND THE PATIENT'S BURN HEALED WITH A MINOR COSMETIC DEFICIT. THE EVENT OCCURRED ON (B)(6) 2020. ON NOV 18, 2020, SITE LEAD PHYSICIAN ADDITIONALLY REPORTED THAT THE RIGHT DISPERSIVE ELECTRODE WAS LOOSE DURING THE CASE, AND THAT THE DE HAD MIGRATED PARTIALLY DOWN THE RIGHT LEG. THE DE WAS RE-POSITIONED WITHOUT INTERRUPTING THE PROCEDURE. THE DOCT

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 10998584 ↗