3M™ Red Dot™ 2268-3Recalls & reported problems
3m Company · 3M™ Red Dot™ ECG Monitoring Electrode, 2268-3, 3 Each/Bag, 200 Bag/Case · 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 10707387789531), received between Jun 21, 2021 and Jun 21, 2021 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A (B)(6) YEAR-OLD FEMALE CUSTOMER REPORTED ANAPHYLACTOID SYMPTOMS AFTER USE OF 3M¿ RED DOT¿ MONITORING ELECTRODE, 2268-3 FOR A CT SCAN. PATIENT HAS AN EXTENSIVE ALLERGY LIST; SHE CARRIES AN ALBUTEROL INHALER AND EPI PEN ROUTINELY. SHE HAS HAD THESE SYMPTOMS FROM PRIOR EXPOSURE TO MANY CHEMICALS. FOUR ELECTRODES WERE APPLIED AND WITHIN FIVE MINUTES SHE EXPERIENCED A BURNING SENSATION UNDER THE ELECTRODE. THE ELECTRODES WERE REMOVED, AND THE SKIN WAS CLEANSED. PATIENT ALLEGED SHE STARTED FEELING ASTHMATIC SYMPTOMS, COUGHING, HEAVY CHEST, VISION CHANGES OF THE ROOM BECOMING DARK AND A "DEEP CLOUD" FEELING. THE NURSING STAFF BROUGHT HER OVER TO URGENT CARE; SHE HAD ALREADY BEEN USING HER ALBUTEROL INHALER; SYMPTOMS WOULD SUBSIDE FOR APPROXIMATELY TEN MINUTES WITH USE OF THE INHALER. WHILE WAITING TO BE SEEN PATIENT SELF-ADMINISTERED HER EPI PEN. LESS THAN FIFTEEN MINUTES LATER THE SYMPTOMS RESOLVED. SHE DISCHARGED HERSELF AND WAS NOT SEEN BY A CLINICIAN.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 12037840 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.