Kendall ES40030Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 20884527004796), received between Jun 20, 2018 and Dec 13, 2021 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryDec 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THE PATIENT WAS RED WITH A RASH AND WAS ITCHY BEYOND THE ELECTRODE AREA. DIRECTIONS FOR ELECTRODE PREP WERE FOLLOWED. THE PATIENT CONSULTED A CLINICIAN AND WAS PRESCRIBED (B)(6).

  Patient problems: Rash

  MAUDE report 12989057 ↗
• InjuryApr 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THE PATIENT STATED THAT SHE EXPERIENCED AN ALLERGIC REACTION TO THE ELECTRODES; HIVES EVERYWHERE ON HER TORSO AND BURNING SKIN. THE PATIENT WENT TO URGENT CARE WHERE THEY REMOVED THE ELECTRODES FROM HER SKIN AND ADVISED HER TO KEEP THEM OFF UNTIL SHE TALKS TO HER CARDIOLOGIST. NO PRESCRIPTIVE TREATMENT WAS RECOMMENDED TO THE PATIENT AT URGENT CARE. SHE WAS ADVISED TO TAKE OVER THE COUNTER BENADRYL. THE PATIENT WAS USING VERMED AND SOFT-E ELECTRODES SIMULTANEOUSLY AND MENTIONED PREVIOUSLY KNOWN SKIN SENSITIVITIES (SEVERE NICKEL ALLERGY). THE PATIENT WAS PRESCRIBED BETAMETHASONE AND TRIAMCINOLONE BY HER PRIMARY CARE PHYSICIAN AND SHE WAS ADVISED TO TAKE OVER THE COUNTER BENADRYL EVERY SIX HOURS AND CORTISONE IN BETWEEN. THE PATIENT USES CALAMINE LOTION OVER THE COUNTER AND HYDROCORTISONE CREAM DUE TO HER SCARRING. INSTRUCTIONS FOR ELECTRODE PREP WERE FOLLOWED.

  Patient problems: Skin Burning Sensation; Urticaria

  MAUDE report 11749934 ↗
• InjuryApr 8, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED THAT THE PATIENT EXPERIENCED SEVERE REDNESS, FLUID DISCHARGE AND RAISED BUMPS. THE PATIENT WAS PREVIOUSLY WEARING VERMED ELECTRODES WHEN THE SKIN IRRITATION FIRST STARTED. THE PATIENT REPORTED SENSITIVE SKIN. THE PATIENT CONSULTED A PHYSICIAN AND WAS PRESCRIBED LOTION AND TOLD TO REMOVE THE ELECTRODES FOR A WEEK.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 11636120 ↗
• InjuryApr 8, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED THAT THE PATIENT EXPERIENCED RAWNESS AND FLUID DISCHARGE IN THE ENTIRE ELECTRODE AREA. THE PATIENT CONSULTED A CLINICIAN AND WAS ADVISED TO DISCONTINUE THE USE OF ELECTRODES THROUGH THE WEEKEND. THE NURSE ADVISED THE USE OF ALCOHOL ON THE SORES AND THE PATIENT WAS PRESCRIBED A CREAM. NO REPORTED SKIN SENSITIVITY OR ALLERGY BY THE PATIENT. IT WAS UNKNOWN IF THE INSTRUCTION FOR ELECTRODE PREPARATION WAS FOLLOWED. ONE PATCH WAS USED BEFORE THIS INCIDENT.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 11636055 ↗
• InjuryJan 22, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED THAT A PATIENT CONTACTED THEM TO REPORT A SKIN IRRITATION RELATED TO THE ELECTRODE. THIS WAS THE SECOND SKIN IRRITATION COMPLAINT REPORTED BY THIS PATIENT. THE PATIENT WAS INITIALLY USING THE VERMED ELECTRODE AND WAS SWITCHED TO THE COVIDIEN SOFT-E ELECTRODE DUE TO SKIN IRRITATION. AFTER FOUR DAYS USING THE COVIDIEN SOFT-E ELECTRODE, THE PATIENT REMOVED THE DEVICE AND CALLED TO REPORT HER SKIN IRRITATION DID NOT IMPROVE, AND HER DOCTOR ADVISED HER TO STOP WEARING THE DEVICE AND PRESCRIBED PREDNISONE. NO PREVIOUS SKIN ALLERGIES OR SENSITIVITIES ARE KNOWN.

  Patient problems: Rash

  MAUDE report 11216105 ↗
• InjuryJan 15, 2021Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT THE PATIENT'S SKIN WAS ITCHY AND HAD BUMPS THAT BURST WITH YELLOW DISCHARGE COMING OUT IN THE ENTIRE ELECTRODE AREA AFTER THE USE OF THREE ELECTRODES. THE PATIENT WAS PREVIOUSLY USING VERMED ELECTRODES BUT WAS SENT SOFT-E ELECTRODES AS A REPLACEMENT FOR THE PATIENT TO CONTINUE ENROLLMENT. THE PATIENT DID NOT REPORT HAVING SENSITIVE SKIN OR ALLERGIES. THE INSTRUCTIONS FOR ELECTRODE PREP WERE FOLLOWED. THE PATIENT DID NOT CONSULT A CLINICIAN, SELF-TREAT, OR SELF-MEDICATE. THERE IS NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Itching Sensation; Skin Infection

  MAUDE report 11178524 ↗
• MalfunctionDec 17, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED THEY WERE PREVIOUSLY USING VERMED ELECTRODES WHEN THE SKIN IRRITATION FIRST STARTED. COVIDIEN SOFT-E ELECTRODES WERE SENT TO THE PATIENT AS AN ALTERNATIVE FOR PATIENTS WITH SENSITIVE SKIN. THE PATIENT IS REPORTING RED BUMPS AND NOW THEY ARE OOZING YELLOW PUS. THE PATIENT HAS ALLERGIES TO ADHESIVES AND CONSULTED A DOCTOR. NO MEDICAL TREATMENT WAS PROVIDED. THE PATIENT SELF TREATED WITH HYDROCORTISONE CREAM AND TRIAMCINOLONE CREAM.

  Patient problems: Skin Infection

  MAUDE report 11027492 ↗
• InjurySep 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT THE PATIENT EXPERIENCED FLUID DISCHARGED BLISTERS, RAISED YELLOWISH COLOR BUMPS, IRRITATION AND ITCHINESS AFTER THE USE OF THREE ELECTRODES. THE PATIENT DID NOT REPORT HAVING SKIN SENSITIVITIES OR ALLERGIES. THE INSTRUCTIONS FOR USE WERE NOT FOLLOWED, THE PATIENT DID NOT REPLACE THE OLD ELECTRODES WITH NEW ONES, INSTEAD THEY REUSED THE ELECTRODES. THE PATIENT DID NOT CONSULT A CLINICIAN, SELF TREAT, OR SELF MEDICATE.

  Patient problems: Skin Irritation; Unspecified Infection

  MAUDE report 10596939 ↗
• InjuryJun 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTS: THE PATIENT DEVELOPED A SKIN RASH SEVERAL DAYS AFTER USE. THE PATIENT WAS PRESCRIBED A STEROID OINTMENT.

  Patient problems: Rash

  MAUDE report 7620117 ↗