Red Dot™ 2269TRecalls & reported problems
3m Company · 3M™ Red Dot™ Neonatal, Pre-Wired, Radiolucent Monitoring Electrode with Clear Tape 2269T, 3/BG 10BG/BX 10BX/CASE · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10707387140929), received between Nov 29, 2022 and Dec 5, 2022 — classified as 3 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
Device problems
- Patient-Device Incompatibility3
Patient problems
- Blister3
- Erythema3
- Skin Maceration3
- Skin Tears3
- Purulent Discharge2
- Swelling/ Edema2
- Rash1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 5, 2022Patient-Device Incompatibility; Patient-Device Incompatibility
A 2-WEEK-OLD FEMALE EXPERIENCED LEFT CHEST/AXILLARY ERYTHEMA, EDEMA, RASH, SKIN TEARS, MACERATION, PURULENT DRAINAGE AND A 3CM X 6CM BLISTER, LESS THAN 24-HOURS POST APPLICATION OF 3M¿ RED DOT¿ NEONATAL, PRE-WIRED, RADIOLUCENT MONITORING ELECTRODE WITH CLEAR TAPE, 2269T LOT 202407AB. MEDICAL TREATMENT WAS REPORTEDLY REQUIRED AND WAS NOTED AS WOUND CARE. EXUFIBER® AG+ WITH HYDROLOCK® AND ALLEVYN SILICONE DRESSINGS WERE APPLIED FOR 4 DAYS, AS THE BLISTERS DRAINED THE PURULENT FLUID. SUBSEQUENTLY, THE ALLEVYN SILICONE DRESSINGS WERE UTILIZED FOR 3 ADDITIONAL DAYS. THE SYMPTOMS REPORTEDLY RESOLVED AFTER 5 DAYS.
Patient problems: Blister; Erythema; Purulent Discharge; Rash; Skin Maceration; Skin Tears; Swelling/ Edema
MAUDE report 15916126 ↗InjuryDec 4, 2022Patient-Device Incompatibility; Patient-Device Incompatibility
A 5-WEEK-OLD MALE EXPERIENCED LEFT UPPER CHEST ERYTHEMA, SKIN TEARS, MACERATION, AND A 4CM X 4CM BLISTER IN LESS THAN 24-HOURS POST APPLICATION OF 3M¿ RED DOT¿ NEONATAL, PRE-WIRED, RADIOLUCENT MONITORING ELECTRODE WITH CLEAR TAPE, 2269T LOT: 202407AB. MEDICAL TREATMENT WAS REPORTEDLY REQUIRED DESCRIBED AS WOUND CARE THAT INCLUDED TREATMENT WITH 3M¿ CAVILON¿ NO STING BARRIER FILM, AND THE SYMPTOMS SUBSEQUENTLY RESOLVED AFTER THREE DAYS.
Patient problems: Blister; Erythema; Skin Maceration; Skin Tears
MAUDE report 15912441 ↗InjuryNov 29, 2022Patient-Device Incompatibility; Patient-Device Incompatibility
A 3-WEEK-OLD FEMALE EXPERIENCED LEFT LOWER CHEST ERYTHEMA, EDEMA, SKIN TEARS, MACERATION AND TWO BLISTERS WITH PURULENT DRAINAGE 24-HOURS POST APPLICATION OF 3M¿ RED DOT¿ NEONATAL, PRE-WIRED, RADIOLUCENT MONITORING ELECTRODE WITH CLEAR TAPE, 2269T. MEDICAL TREATMENT WAS REPORTEDLY REQUIRED AND WAS NOTED AS WOUND CARE CONSULT. EXUFIBER® AG+ WITH HYDROLOCK® AND ALLEVYN SILICONE DRESSINGS WERE APPLIED FOR 4 DAYS, AS THE BLISTERS DRAINED THE PURULENT FLUID. SUBSEQUENTLY, ALLEVYN SILICONE DRESSINGS WERE UTILIZED FOR 3 ADDITIONAL DAYS.
Patient problems: Blister; Erythema; Purulent Discharge; Skin Maceration; Skin Tears; Swelling/ Edema
MAUDE report 15876389 ↗
Other Electrode, electrocardiograph devices
- Vermed A10091-30Graphic Controls Acquisition Corp · Electrode, Electrocardiograph132 reports
- 3M™ 22283m Company · Electrode, electrocardiograph2 recalls0 reports
- 3M™ Red Dot™ 22283m Company · Electrode, electrocardiograph1 recall4 reports
- Vital Signs™ 2464AAO-20AirLife Finland Oy · Electrode, electrocardiograph51 reports
- Vermed IP-Set M5 RT Adult-USGraphic Controls Acquisition Corp · Electrode, Electrocardiograph1 recall0 reports
- Vermed IP-Set 12 RT Adult-USGraphic Controls Acquisition Corp · Electrode, Electrocardiograph1 recall0 reports
- Vermed IP-Set N3-Pediatric-USGraphic Controls Acquisition Corp · Electrode, Electrocardiograph1 recall0 reports
- Vermed IP-Set M3 RT Adult-USGraphic Controls Acquisition Corp · Electrode, Electrocardiograph1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.