BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3M RED DOT MONITORING ELECTRODE

    MDR report key: 1811260 · Received August 11, 2010

    Report

    Report Number
    2110898-2010-00095
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    January 1, 2010
    Report Date
    August 10, 2010
    Manufacturer
    3M HEALTH CARE
    Product Code
    DRX
    PMA / PMN Number
    K970796
    Removal / Correction Number
    2110898-07/22/010-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE (B)(4) RED DOT FOAM ELECTRODE SNAP WAS RUSTY. OUR TESTING HAS CONFIRMED PRODUCT DOES NOT MEET SPECIFICATION, A CORRECTIVE ACTION HAS BEEN IMPLEMENTED AND A RECALL HAS BEEN INITIATED FOR THE RETURN OF AFFECTED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M RED DOT MONITORING ELECTRODE ECG ELECTRODE DRX 3M HEALTH CARE NA 2012-05-CE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other