BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3M¿ RED DOT¿

    MDR report key: 23050818 · Received September 15, 2025

    Report

    Report Number
    23050818
    Event Type
    Malfunction
    Date Received
    September 15, 2025
    Date of Event
    August 7, 2025
    Report Date
    August 12, 2025
    Manufacturer
    3M COMPANY
    Product Code
    DRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RED DOT ELECTRODES KEPT LIFTING OFF THE PATIENT'S SKIN AFTER APPLYING THE ALLIGATOR CLIPS FROM THE EKG [ELECTROCARDIOGRAM] MACHINE. RED DOT PACKAGES CHECKED FOR EXPIRATION DATE (02-19-2027 ON PACKAGE) DISCARDED OPEN RED DOT PACKAGES AND USED NEWLY OPENED PACKAGE WITH SAME ISSUE NOTED. TO BE ABLE TO COMPLETE THE EKG, THE RED DOT ELECTRODES NEEDED TO BE HELD DOWN TO PREVENT THEM FROM LIFTING OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2501240 3M¿ RED DOT¿ ELECTRODE, ELECTROCARDIOGRAPH DRX 3M COMPANY 2360 202702CB

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female