Red Dot™ 2255-50Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10707387569584), received between Mar 22, 2018 and Feb 26, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Patient Device Interaction 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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  A CONSUMER REPORTED FOUR 2255-50 3M¿ RED DOT¿ SOFT CLOTH MONITORING ELECTRODES WERE APPLIED FOR CARDIAC MONITORING. THE CONSUMER ALLEGEDLY EXPERIENCED A BRIGHT RED RAISED RASH, EXTREME ITCHING AND OOZING THREE DAYS AFTER APPLICATION OF THE ELECTRODES. THE ELECTRODES AND CARDIAC MONITORING WERE DISCONTINUED. THE REACTION STARTED TO SPREAD OUTSIDE THE AREA WHERE THE ELECTRODES WERE APPLIED. THE CONSUMER REPORTEDLY CONSULTED A DERMATOLOGIST AND WAS TREATED WITH A TOPICAL RX OINTMENT.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 8370845 ↗
• InjuryAug 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED FOUR 2255-50 3M¿ RED DOT¿ SOFT CLOTH MONITORING ELECTRODES WERE APPLIED FOR A HOME CARDIAC MONITORING TEST. THE CONSUMER REPORTEDLY EXPERIENCED ITCHING AND BURNING SHORTLY AFTER APPLICATION. SHE REPORTEDLY CHANGED THE ELECTRODES DAILY. THE REACTION PROGRESSED TO REDNESS, RASH AND SEVERE IRRITATION WHERE THE ELECTRODES HAD BEEN APPLIED. SHE DISCONTINUED USE OF THE ELECTRODES AFTER 5 DAYS DUE TO THE SKIN REACTION. OTC CORTISONE CREAM, ALOE VERA, AND MENTHOL WERE INITIALLY APPLIED FOR TREATMENT. THE REACTION DID NOT IMPROVE, AND SHE STARTED TO EXPERIENCE A LOW-GRADE FEVER AND CHILLS. A DERMATOLOGIST WAS CONSULTED, AND SHE WAS GIVEN A PRESCRIPTION FOR TRIAMCINOLONE 0.1% OINTMENT AND ORAL CEPHALEXIN 500 MG. TWO DAYS FOLLOWING USE OF THE MEDICATIONS, THE CONSUMER REPORTED THREE OF THE AREAS WERE CLEARED UP AND THE FOURTH AREA WAS IMPROVING.

  Patient problems: Reaction; Skin Irritation

  MAUDE report 7758337 ↗
• InjuryMar 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED FOUR 2255-50 3M¿ RED DOT¿ SOFT CLOTH MONITORING ELECTRODES WERE APPLIED TO HER CHEST FOR A HOLTER CARDIAC MONITORING TEST. THE CONSUMER ALLEGED SHE EXPERIENCED ITCHING AND A BRIGHT RED SKIN REACTION THAT "LOOKED LIKE A BURN" UNDER THE ADHESIVE PORTION OF EACH ELECTRODE WITHIN 24 HOURS OF APPLICATION. THE ELECTRODES WERE DISCONTINUED AND THE SKIN AREAS WERE CLEANSED. THE REACTION WAS REPORTED TO HER MD WHO RECOMMENDED AN UNSPECIFIED TOPICAL OINTMENT. THE CONSUMER REPORTED SHE DID NOT USE/APPLY THE TOPICAL OINTMENT. THE REACTION REPORTEDLY HEALED BUT THE CONSUMER ALLEGED SHE HAS SCARRING.

  Patient problems: Erythema; Itching Sensation; Scarring

  MAUDE report 7362190 ↗