Kendall 31013926 (REF 31013926-)Recalls & reported problems
Cardinal Health 200, LLC · Kendall 500 series Diaphoretic Foam Monitoring electrode - Tear drop shape ( 30/PK) · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20192253017196), received between Mar 24, 2026 and Mar 24, 2026 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED THAT THEY HAVE DEVELOPED A SEVERE ALLERGY TO THE ADHESIVE ELECTRODES USED DURING TREATMENT. THE PATIENT HAD AN EXTENSIVE RASH THAT STARTED IN THE MIDDLE OF THEIR FACE AND DESCENDED TO THEIR KNEES. THE AREA WAS BRIGHT RED AND THEY HAD AN INTENSE BURNING SENSATION ACCOMPANIED BY SEVERE ITCHING, TREMBLING AND CHILLS. NO PRODUCT WAS APPLIED BEFORE THE ELECTRODES. ABOUT 1/2 HOUR AFTER THE PLACEMENT OF THE ELECTRODES THE SKIN REACTION APPEARED WHILE THE ELECTRODES WERE STILL ON THEIR SKIN. THE FIRST TREATMENT WAS ORAL AND IT DIDN'T HELP KEEP THE REACTION FROM PROGRESSING. INTRAVENOUS CORTICOSTEROIDS WERE GIVEN AND THE PATIENT WAS UNDER OBSERVATION ON A HEART MONITOR AND BLOOD PRESSURE, LYING ON A STRETCHER. THE PATIENT HAD TO UNDERGO A SECOND INTRAVENOUS CORTICOSTEROIDS TREATMENT WHICH WORKED.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 24679862 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.