BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M RED DOT MONITORING ELECTRODE

    MDR report key: 2062644 · Received April 11, 2011

    Report

    Report Number
    2110898-2011-00038
    Event Type
    Injury
    Date Received
    April 11, 2011
    Date of Event
    January 3, 2011
    Report Date
    March 17, 2011
    Manufacturer
    3M HEALTH CARE
    Product Code
    DRX
    PMA / PMN Number
    K970796
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. CONCLUSIONS: NO EVALUATION WILL BE PERFORMED. REMEDIAL ACTION - THIS CATALOG NUMBER WAS SUBJECT TO A RECALL ON AN UNRELATED QUALITY ISSUE.

    Description of Event or Problem · 1

    THE 3M RECEIVED INFORMATION THAT A CUSTOMER WAS ADMITTED TO THE EMERGENCY ROOM (ER) FOR ATRIAL FIBRILLATION ON (B)(6) 2010 AND DEVELOPED BLISTERY REDNESS WITH LITTLE DARK RED DOTS UNDER THE ENTIRE ELECTRODE FOR ALL 6-8 LEADS. THE CUSTOMER DID NOT KNOW WHAT ELECTRODE WAS USED, BUT THE ER TOLD HER THAT THEY WERE 2560S (3M RED DOT MONITORING ELECTRODES). HER SKIN REACTION WAS SUCCESSFULLY TREATED WITH SILVADENE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M RED DOT MONITORING ELECTRODE 870.2360 ELECTROCARDIOGRAPH ELECTRODE DRX 3M HEALTH CARE NA NK

    Patients

    Seq Age Sex Outcome Treatment
    1 NK Required Intervention NK