BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRODE, ECG, MONITORING, SS SNAP, FOA

    MDR report key: 5294959 · Received December 14, 2015

    Report

    Report Number
    1423537-2015-00075
    Event Type
    Malfunction
    Date Received
    December 14, 2015
    Date of Event
    September 13, 2015
    Report Date
    December 14, 2015
    Manufacturer
    INTCO MEDICAL CO.
    Product Code
    DRX
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    ID
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORD COULD NOT BE VERIFIED AS A LOT NUMBER WAS NOT PROVIDED. NO SAMPLES WERE RECEIVED FOR EVALUATION SO THEREFORE THE SUPPLIER IS UNABLE TO DETERMINE A ROOT CAUSE FOR THE ISSUE REPORTED. A REVIEW OF HISTORICAL COMPLAINT RECORDS FROM 2004 THROUGH 2015 SHOWED NO INCIDENCE OF BURNS REPORTED. REVIEW OF THE MATERIAL RECORD SHOWED THAT THE MATERIALS ARE IN COMPLIANCE FOR BIOCOMPATIBILITY. THE REPORTED INCIDENT COULD NOT BE REPEATED OR CONFIRMED IN THIS INVESTIGATION. WE WILL CONTINUE TO MONITOR FOR ANY SIMILAR REPORTS.

    Description of Event or Problem · 1

    THE CUSTOMER, (B)(6) STATE PATROL OFFICER, ALLEGEDLY SUSTAINED BURNS ON HER CHEST AND ABDOMEN DURING A ECG PROCEDURE THAT WAS PERFORMED AT (B)(6). SHE REPORTS THAT SHE DOES NOT BELIEVE THAT THE LEAD OR ELECTRODES ARE TO BLAME FOR THE BURN, BUT BELIEVES IT WAS CAUSED DUE TO BEING PREPPED INCORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822459 ELECTRODE, ECG, MONITORING, SS SNAP, FOA ELECTRODE, ELECTROCARDIOGRAPH DRX INTCO MEDICAL CO. E510FATM NO LOT GIVEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other