Kendall 31424768Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20884527005007), received between Oct 20, 2021 and Oct 20, 2021 — 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.

• InjuryOct 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT THE ELECTRODE WAS REMOVED FROM THE SKIN LEAVING BEHIND A SMALL 2X2CM SKIN ABRASION WHICH WAS OOZING. PER ADDITIONAL INFORMATION RECEIVED, THE BABY HAD PUS LIKE FLUID DRAINING FROM THE AFFECTED SITE. INITIAL CARE OF A SALINE CLEAN AND A COMFEEL COVERING WAS GIVEN. THE PEDIATRICIAN PRESCRIBED BACTROBAN OINTMENT IN THE HOSPITAL AND THE BABY WENT HOME FULLY HEALED. THERE WAS NO MEDICAL PROCEDURE FOR THE SKIN LESION. THE DURATION OF USE OF THE ELECTRODE WAS FOR ABOUT 2 DAYS.

  Patient problems: Abrasion

  MAUDE report 12668704 ↗
• InjuryOct 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT THE ELECTRODE TOOK OFF TOP LAYER OF THE SKIN LEAVING BEHIND A 2.5X2.5 CM LESION OOZING GREEN FLUID. PER ADDITIONAL INFORMATION RECEIVED, INITIAL CARE OF A SALINE CLEAN AND A COMFEEL COVERING WAS GIVEN. THE PEDIATRICIAN PRESCRIBED BACTROBAN OINTMENT IN THE HOSPITAL AND THE BABY WENT HOMED FULLY HEALED. THERE WAS NO MEDICAL PROCEDURE FOR THE SKIN LESION. THE DURATION OF USE OF THE ELECTRODE WAS FOR ABOUT 2 DAYS.

  Patient problems: Localized Skin Lesion

  MAUDE report 12665626 ↗