Red Dot™ 2560Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10707387463257), received between Feb 7, 2019 and Apr 26, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (3 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 26, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  A HOSPITAL REPORTED A PATIENT ALLEGEDLY EXPERIENCED SKIN DAMAGE WITH THE USE OF THE 3M¿ RED DOT¿ MONITORING ELECTRODE WITH FOAM TAPE AND STICKY GEL, 2560. ONE WEEK POST APPLICATION OF THE 3M¿ RED DOT¿ MONITORING ELECTRODE WITH FOAM TAPE AND STICKY GEL, THE PATIENT REMOVED THE ELECTRODES AND REPORTEDLY OBSERVED A 2CM X 3CM AREA OF SKIN DAMAGE WITH NO BLEEDING. THE AREA IMPROVED POST DISINFECTION, AND ADMINISTRATION OF MEDICATION, TYPE NOT PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Skin Tears

  MAUDE report 16818219 ↗
• InjuryApr 6, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  A CUSTOMER ALLEGED A PATIENT EXPERIENCED CONTACT DERMATITIS WITH BLISTERING THAT REQUIRED TOPICAL TRIAMCINOLONE CREAM TREATMENT AND A DELAY IN SURGERY WITH THE USE OF THE 3M¿ RED DOT¿ MONITORING ELECTRODE WITH FOAM TAPE AND STICKY GEL, 2560.

  Patient problems: Blister; Contact Dermatitis

  MAUDE report 16694116 ↗
• InjuryApr 6, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORT RECEIVED FROM THE FDA VIA MEDWATCH FORM MW5115239. A NURSE REPORTED A PATIENT ALLEGEDLY EXPERIENCED A 1-INCH X 0.5 INCH LEFT UPPER CHEST SKIN TEAR WITH ERYTHEMA, AND BLEEDING POST REMOVAL OF 3M¿ RED DOT¿ MONITORING ELECTRODE WITH FOAM TAPE AND STICKY GEL 2560, LOT 2024-11 CY THAT REPORTEDLY REQUIRED MEDICAL TREATMENT DESCRIBED AS "FIRST AID." ON POSTOPERATIVE DAY 1, THE SKIN TEAR APPEARED TO BE HEALING WITH SCANT SEROSANGUINOUS DRAINAGE AND SCABBING PRESENT ALONG EDGES OF THE SKIN TEAR. NO PURULENCE OR ACTIVE BLEEDING WAS OBSERVED. THE PATIENT REPORTEDLY HAS A HISTORY OF SKIN SENSITIVITIES DUE TO "THIN SKIN." NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Skin Tears

  MAUDE report 16690433 ↗
• InjuryFeb 13, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  A FEMALE PATIENT ALLEGEDLY EXPERIENCED A RIGHT ANKLE SKIN REACTION WITH ERYTHEMA, SORENESS TO THE TOUCH, BLISTERING, WITH POST REMOVAL ITCHY SENSATION WITH THE USE OF 3M¿ RED DOT¿ MONITORING ELECTRODE WITH FOAM TAPE AND STICKY GEL, 2560. THE ELECTRODES WERE PLACED UPON HOSPITAL ADMISSION ON (B)(6) 2022. WITHIN A TWO-WEEK PERIOD, THE PATIENT REPORTEDLY HAD "MANY" ELECTRODES APPLIED AT VARIOUS LOCATIONS ON THE BODY THAT WERE CHANGED WHILE THE ANKLE ELECTRODE REMAINED IN PLACE AND WAS NOT CHANGED AT ANY POINT THROUGHOUT THE 2-WEEK HOSPITALIZATION. ON (B)(6) 2022, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH THE ANKLE ELECTRODE REPORTEDLY STILL ATTACHED AND IT WAS NOTED THAT "IT MAY HAVE BEEN LEFT ON ACCIDENTALLY." ON (B)(6) 2023, THE PATIENT REPORTEDLY REMOVED THE ELECTRODE AT HOME AND ALLEGEDLY OBSERVED REDNESS AT THE ANKLE ELECTRODE SITE. ON (B)(6) 2022, A DERMATOLOGIST OBSERVED THE PATIENT AND ADVISED TO APPLY ADVANTAN® CORTICOSTEROID CREAM WHICH REPORTEDLY DID NOT WORK, AS THE RASH WAS ALLEGEDLY SPREADING. THE PATIENT WAS EXPERIENCING REDNESS WITH AN ITCHING SENSATION AND NO SKIN STRIPPING. ON (B)(6) 2023, IT WAS REPORTED THAT TREE OIL WAS APPLIED TWICE TO RELIEVE THE ITCHING

  Patient problems: Blister; Erythema; Itching Sensation; Pain; Rash; Skin Inflammation/ Irritation

  MAUDE report 16363229 ↗
• InjuryFeb 7, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  A CONSUMER REPORTEDLY EXPERIENCED AN ALLERGIC REACTION DESCRIBED AS ITCHING, REDNESS, SWELLING, BLISTERS, FOLLICULITIS AND SKIN TEARS FOLLOWING USE OF 2560 3M¿ RED DOT¿ FOAM MONITORING ELECTRODES. THE CONSUMER ALSO REPORTED EXPERIENCING GENERAL MALAISE, FATIGUE AND HEADACHES. DERMATOLOGY AND ALLERGY SPECIALISTS WERE CONSULTED. THE REACTION WAS TREATED WITH AND UNSPECIFIED TYPE OF ALLERGY MEDICATION AND CORTISONE CREAM. THE CONSUMER REPORTED THE SKIN WAS NO LONGER OPEN AND MINIMAL SCARING OCCURRED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 8316340 ↗