Kendall 31.1355821Recalls & reported problems
Cardinal Health 200, LLC · Kendall H135TSG Radiolucent, Foam Monitoring electrode with Hydrogel 43x35mm · Class 2
All models of Kendall (31)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 20192253016885), received between Aug 21, 2025 and Aug 21, 2025 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Partial thickness (Second Degree) Burn1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED THAT DURING A WASH/BATH, WHEN CHANGING THE DEVICES, THE NURSE OBSERVED 2 BURNS UNDER TWO ELECTRODES OF 2 CM IN DIAMETER. THESE BURNS ARE ASSOCIATED WITH THE GEL PRESENT IN THE COMPOSITION OF THE ELECTRODE SINCE THE SURFACE BURNT SKIN IS IDENTICAL TO THE GEL CONTAINED IN THE ELECTRODES. ONE BLISTER HAS THE PRESENCE OF PURULENT FLUID AND THE OTHER BLISTER HAS RUPTURED. THE SKIN UNDERNEATH HAS AN ERYTHEMA. THERE WERE NO CREAMS OR ANY OTHER PRODUCT ON THE BABY'S SKIN. TREATMENT INVOLVED BURN CARE WITH PRESCRIPTION AND ADJUSTMENT OF ANALGESIC TREATMENT. THE CHILD HAD BEEN EXPERIENCING PAIN FOR SEVERAL HOURS, ASSESSED UNDER EVENDOL3 0 6/15 DESPITE CONTINUOUS ADMINISTRATION OF MORPHINE AND ADMINISTRATION OF LEVEL 1 ANALGESIC. FAILURE OF HEALING, RISK OF INFECTION.
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 22865596 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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