CARDINAL HEALTH EPP3CRRecalls & reported problems
Cardinal Health 200, LLC · Monitoring Electrode, Neonatal, Prewired, Cloth · 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 00885380048473), received between Sep 6, 2017 and Sep 6, 2017 — 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
- Lead(s), Burn(s) From1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
USER FACILITY REPORTED A POSSIBLE BURN FROM NEONATAL LEADS. LEADS WERE CHANGED 24 HOURS PRIOR TO EVENT DATE (B)(6) 2017. AT TIME OF EVENT BEDSIDE NURSE CHANGED LEADS TO THE NEOLEAD MICRO ELECTRODES. GREEN LEAD WAS AFFECTED AND CHANGED. PATIENT SITE REVIEWED AND LEFT MID ABDOMEN FOUND TO HAVE AN INTACT FLAT BLISTER CIRCULAR 1 CM X 1 CM AREA WITH A FAINT ERYTHEMATOUS CIRCULAR REGION THE SIZE OF THE ELECTRODE. FLAT BLISTER APPEARS INTACT WITH SCANT DRY EXUDATE.
Patient problems: Lead(s), Burn(s) From
MAUDE report 6846555 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.