BEUDAMED
    FDA Adverse Event Other Summary report: N

    MARQUETTE DIAGNOSTICS ECG ELECTRODES

    MDR report key: 754428 · Received August 24, 2006

    Report

    Report Number
    1320208-2006-00061
    Event Type
    Other
    Date Received
    August 24, 2006
    Date of Event
    June 27, 2006
    Report Date
    August 24, 2006
    Manufacturer
    CONMED CORP.
    Product Code
    DPS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE SKIN HAD BEEN PREPPED USING BOTH PUMAS AND ALCOHOL. AGGRESSIVE USE OF THE PUMAS &/OR FAILURE TO ALLOW THE ALCOHOL TO DRY COULD ACCOUNT FOR THE REPORTED SKIN IRRITATION. REVIEW OF THE DHR AND VISUAL EXAMINATION INDICATES THESE ELECTRODES WERE MADE TO SPECIFICATION. A SEARCH OF PRODUCT COMPLAINT DATABASE DID NOT REVEAL ANY SIMILAR COMPLAINTS. WE FEEL THIS IS AN ISOLATED INCIDENT. THIS INVESTIGATION IS COMPLETE AND THE COMPLAINT IS CLOSED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "WHEN ELECTRODE IS REMOVED FROM PATIENT IT LEAVES MARKS RANGING FROM RED, SWOLLEN AND ITCHY TO OPEN FLESH WOUNDS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARQUETTE DIAGNOSTICS ECG ELECTRODES DIAGNOSTICS ECG ELECTRODES DPS CONMED CORP. NA 0512201

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other