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Red Dot™ 2284Recalls & reported problems

3m Company · 3M™ Red Dot™ Neonatal Limb Band Monitoring Electrode, Pre-Wired 2284 · 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 50707387468571), received between Aug 30, 2023 and Aug 30, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Human-Device Interface Problem” (1 report).

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

  • Human-Device Interface Problem1

Patient problems

  • Bruise/Contusion1
  • Burn(s)1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 30, 2023Human-Device Interface Problem; Human-Device Interface Problem

    A HOSPITAL RISK MANAGER REPORTED A NEONATE ALLEGEDLY EXPERIENCED A 10MM X 10MM LOCALIZED SKIN BURNED/BRUISED WITH A PURPLE/RED APPEARANCE WITH THE USE OF THE 3M¿ RED DOT¿ ECG MONITORING ELECTRODES, NEONATAL, PRE-WIRED, LIMB BAND, 2284. THE WIRE TO THE LEAD WAS REPORTEDLY NOT CONNECTED TO THE ADHESIVE PORTION, APPEARED FRAYED, AND WAS "STUCK" TO THE PATIENT'S SKIN. NO MEDICAL INTERVENTION WAS REPORTED.

    Patient problems: Bruise/Contusion; Burn(s)

    MAUDE report 17653215 ↗

Other Electrode, electrocardiograph devices

All Electrode, electrocardiograph devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.