Kendall 31.1245.21Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20192253016854), received between Aug 14, 2024 and Jan 17, 2025 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED SKIN BURN IN YOUNG PATIENTS. ADDITIONAL INFORMATION RECEIVED ON (B)(6)2025 STATED THAT THE BURNING PHENOMENON IS RECENT AND AFFECTED 4 CHILDREN. BURNS ARE VARIABLE (BLISTER WITH DEEPER BURNS) AND ARE MORE LIKELY TO BE BETWEEN THE 2ND AND 3RD DEGREE. SOME CHILDREN HAD TO RECEIVE TREATMENT FOR BURNS. THIS CASE IS FOR PATIENT 1.

  Patient problems: Blister; Full thickness (Third Degree) Burn; Partial thickness (Second Degree) Burn

  MAUDE report 21184385 ↗
• InjuryJan 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED SKIN BURN IN YOUNG PATIENTS. ADDITIONAL INFORMATION RECEIVED ON 06JAN2025 STATED THAT THE BURNING PHENOMENON IS RECENT AND AFFECTED 4 CHILDREN. BURNS ARE VARIABLE (BLISTER WITH DEEPER BURNS) AND ARE MORE LIKELY TO BE BETWEEN THE 2ND AND 3RD DEGREE. SOME CHILDREN HAD TO RECEIVE TREATMENT FOR BURNS. THIS CASE IS FOR PATIENT (B)(6).

  Patient problems: Blister; Full thickness (Third Degree) Burn; Partial thickness (Second Degree) Burn

  MAUDE report 21184368 ↗
• InjuryJan 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED SKIN BURN IN YOUNG PATIENTS. ADDITIONAL INFORMATION RECEIVED ON 06JAN2025 STATED THAT THE BURNING PHENOMENON IS RECENT AND AFFECTED 4 CHILDREN. BURNS ARE VARIABLE (BLISTER WITH DEEPER BURNS) AND ARE MORE LIKELY TO BE BETWEEN THE 2ND AND 3RD DEGREE. SOME CHILDREN HAD TO RECEIVE TREATMENT FOR BURNS. THIS CASE IS FOR PATIENT (B)(6).

  Patient problems: Blister; Full thickness (Third Degree) Burn; Partial thickness (Second Degree) Burn

  MAUDE report 21184315 ↗
• InjuryJan 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED SKIN BURN IN YOUNG PATIENTS. ADDITIONAL INFORMATION RECEIVED ON 06JAN2025 STATED THAT THE BURNING PHENOMENON IS RECENT AND AFFECTED 4 CHILDREN. BURNS ARE VARIABLE (BLISTER WITH DEEPER BURNS) AND ARE MORE LIKELY TO BE BETWEEN THE 2ND AND 3RD DEGREE. SOME CHILDREN HAD TO RECEIVE TREATMENT FOR BURNS. THIS CASE IS FOR PATIENT 2.

  Patient problems: Blister; Full thickness (Third Degree) Burn; Partial thickness (Second Degree) Burn

  MAUDE report 21184256 ↗
• InjuryAug 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT THE CHILD WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2024 FOR "COUGH AND PHLEGM FOR MORE THAN 10 DAYS", AND ON (B)(6) , THE CHILD WAS RESCUED WITH A T36.9°C, PULSE RATE OF 180 BEATS/MIN, AND BREATHING OF 46 BREATHS/MIN, AND WAS GIVEN A DISPOSABLE ELECTROCARDIOGRAM TO MONITOR THE ELECTROCARDIOGRAM AT 14:47 ON (B)(6). ON (B)(6) 2024, THE NURSE FOUND A RED RASH ON THE SITE OF THE ELECTRODE PATCH ON THE CHILD, REPORTED TO THE DOCTOR. ACCORDING TO THE DOCTOR'S INSTRUCTIONS, REMOVED THE ELECTRODE AND APPLIED DEXAMETHASONE ACETATE CREAM, AND TOLD THE FAMILY TO KEEP THE SKIN DRY AND CLEAN. ON (B)(6), THE NURSE FOUND THAT THE CHILD'S RED RASH HAD LARGELY SUBSIDED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 19981448 ↗