Kendall 31115788Recalls & reported problems
Cardinal Health, Inc. · Electrodes,535 Foam Conductive Adhesive Hydrogel · 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 20884527008039), received between Sep 28, 2020 and Sep 28, 2020 — 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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Necrosis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED THAT THE ELECTRODE CAUSED NECROSIS ON A BURN PATIENT. THE PATIENT HAD ELECTRODES ON FROM (B)(6) 2020 UNTIL (B)(6) 2020, WITH THE ELECTRODES BEING CHANGED EVERY THREE DAYS. THE ELECTRODES WERE PLACED DIRECTLY ON THE PATIENT'S SKIN. THE CARDIAC MONITOR WAS IMMEDIATELY EVALUATED BY BIOMED FOR PROPER FUNCTION. A SKIN BIOPSY WAS DONE AND THE WOUNDS WERE LEFT IN THE AIR FOR DRYING. THERE WAS NO MEDICATION PRESCRIBED. SURGICAL DEBRIDEMENT IS BEING PERFORMED AS NEEDED. THE PATIENT IS CURRENTLY DOING VERY WELL.
Patient problems: Necrosis
MAUDE report 10596949 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.