Red Dot™ 2660-5Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10707387507845), received between May 15, 2018 and Oct 11, 2019 — classified as 3 injuries.

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.

• InjuryOct 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DISTRIBUTOR REPORTED THAT A PATIENT ALLEGED SKIN IRRITATION, DESCRIBED AS A BLISTER/BURN IN TWO AREAS OF THE CHEST, THAT BEGAN APPROXIMATELY ONE WEEK AFTER MONITORING USING 3M¿ RED DOT¿ ECG REPOSITIONABLE SOFT CLOTH MONITORING ELECTRODES, 2660-5. THE PATIENT INFORMED THE DISTRIBUTOR OF THE ALLEGED SYMPTOMS AFTER APPROXIMATELY 20 DAYS OF MONITORING AND HAD DISCONNECTED THE MONITORING SYSTEM. UPON FOLLOW-UP BY THE DISTRIBUTOR ONE MONTH LATER, THE PATIENT REPORTED THAT THE SKIN WAS PINK AND PEELING. THE PATIENT VISITED HER CARDIOLOGIST AND NO TREATMENT WAS PRESCRIBED. A MEDWATCH REPORT WAS RECEIVED BY THE DISTRIBUTOR (MW5078271) THAT THE PATIENT HAD SUBMITTED TO THE FDA WHICH INDICATED THAT AN AREA IN THE CENTER OF THE CHEST LOOKED TO BE A PERMANENT SCAR.

  Patient problems: Scarring; Skin Irritation

  MAUDE report 9182944 ↗
• InjuryMay 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED 3M RED DOT ELECTRODES AND A BODYGUARDIAN® VERITE HEART MONITOR WERE BEING USED FOR A 30-DAY CARDIAC MONITORING TEST. THE CONSUMER REPORTEDLY WORE THE ELECTRODES FOR 13 DAYS WITHOUT ISSUE. ON THE 14 DAY, SHE REPORTEDLY STARTED TO EXPERIENCE A "TINGLING SENSATION" UNDER THE ELECTRODE STUBS AND THE FOLLOWING DAY, THE "TINGLING SENSATION" BECAME INTENSE. THE CONSUMER REPORTED THE MONITOR AND LEAD WIRES WERE HEATING UP. THE CONSUMER STATED SHE WAS SEEN IN AN URGENT CARE AND DIAGNOSED WITH "2ND DEGREE ELECTRICAL BURNS ON FOUR CHEST SITES DUE TO A FAULTY ELECTRODE MONITOR." SHE WAS REPORTEDLY GIVEN A PRESCRIPTION FOR SILVADENE CREAM AND RECEIVED A TETANUS (TDAP) SHOT. SHE WAS INSTRUCTED TO FOLLOW-UP THE SAME DAY AT A WALK-IN CLINIC TO EVALUATE THE SKIN BURNS AND WAS SEEN BY A DERMATOLOGIST. SHE WAS GIVEN AN RX FOR SANTYL OINTMENT, INSTRUCTED TO TAKE IBUPROFEN. SHE WAS ALSO INSTRUCTED TO FOLLOW-UP WITH HER CARDIOLOGIST.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 8612001 ↗
• InjuryMay 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED 2660-5 3M¿ RED DOT¿ MONITORING ELECTRODES WERE APPLIED TO FOUR SITES ON HER CHEST FOR A HOLTER MONITOR EXAM. THE WOMAN INITIALLY ALLEGED ITCHING, REDNESS, BURNING AND SKIN REMOVAL OCCURRED UNDER THE ELECTRODES SITES AND DARK ROUGH SPOTS REMAINED FOLLOWING THE REACTION. NO MEDICAL TREATMENT WAS REPORTED. THE WOMAN LATER CONTACTED 3M AND ALLEGED SHE HAS SCARING WHERE THE ELECTRODES WERE APPLIED.

  Patient problems: Skin Discoloration; Skin Irritation

  MAUDE report 7514980 ↗