BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CFM MODEL 6000 HYDROGEL ELECTRODES

    MDR report key: 1980245 · Received February 2, 2011

    Report

    Report Number
    3018859-2011-00001
    Event Type
    Injury
    Date Received
    February 2, 2011
    Date of Event
    January 4, 2011
    Report Date
    February 2, 2011
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    GWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CFM HYDROGEL ELECTRODES ARE MANUFACTURED FOR NATUS MEDICAL INCORPORATED BY COVIDIEN. COVIDIEN WAS NOTIFIED OF THIS CUSTOMER COMPLAINT AND REPORTED THAT THERE HAVE BEEN NO RAW MATERIAL OR GEL FORMULATION CHANGES WITH THE HYDROGEL AND NO TREND IN SKIN IRRITATION COMPLAINTS. THE HYDROGEL HAS BEEN BIOCOMPATIBILITY TESTED PER (B)(4). THE CFM HYDROGEL LABELING STATES: "THERE IS THE POSSIBILITY THAT PTS MAY EXPERIENCE SKIN IRRITATION AT CONTACT POINTS WITH THE ELECTRODES." HOWEVER, THE EXTENT OF SKIN DAMAGE REPORTED HERE WAS MODERATE TO SEVERE. THERE HAS BEEN ONE OTHER COMPLAINT OF THIS NATURE FOR THE CFM HYDROGEL ELECTRODES; IT WAS REPORTED BY A HOSPITAL IN (B)(6) (SEE MDR 3018859-2010-00005 FOR DETAILS). ONE POSSIBLE CAUSE IS PT SKIN SENSITIVITIES / ALLERGIES. ANOTHER POSSIBILITY IS EXCESS PRESSURE APPLIED TO THE SKIN BY THEIR TECHNIQUE OF SECURING THE ELECTRODES IN PLACE WITH A BANDAGE. HOWEVER, NO CLEAR ROOT CAUSE HAS BEEN DETERMINED FOR THIS EVENT. NATUS MEDICAL INCORPORATED HAS NO CORRECTIVE ACTIONS PLANNED BUT WILL CONTINUE TO MONITOR ALL CUSTOMER FEEDBACK FOR THE CFM HYDROGEL ELECTRODES AND WILL REVIEW FOR REPORTABILITY AND TRENDS AS APPROPRIATE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, NATUS MEDICAL INCORPORATED WAS INFORMED THAT A (B)(6) INFANT EXPERIENCED SKIN DAMAGE FOLLOWING USE OF CFM MODEL 6000 HYDROGEL ELECTRODES. THE ELECTRODES WERE CHANGED TWO TIMES DURING THE FIRST 36 HOURS OF MONITORING. THE ELECTRODES WERE THEN REMOVED FOR AN MRI. A NEW SET OF ELECTRODES WAS PLACED POST-MRI AND REMAINED IN PLACE FOR 12 HOURS. CFM MONITORING WAS THEN DISCONTINUED AND THE ELECTRODES WERE LEFT IN PLACE FOR 3 HOURS WHILE THE INFANT SLEPT. UPON REMOVING THE ELECTRODES, THE SKIN BENEATH THE CENTER LEAD LOOKED SLIGHTLY RED. A FEW HOURS LATER, BLISTERS APPEARED AND THE SKIN LOOKED LIKE IT HAD BEEN SEVERELY BURNED IN THE AREAS WHERE ALL THREE LEADS HAD BEEN PLACED. THERE WERE CIRCULAR BLISTERS AND DEEP REDNESS AROUND THE BLISTERS. THE SKIN WAS INTACT WITH NO REDNESS IDENTIFIED (PRE-MRI) PRIOR TO PLACING THIS LAST SET OF ELECTRODES ON THE INFANT. PRIOR TO ELECTRODE PLACEMENT, THE SKIN WAS CLEANED AND PREPPED WITH NUPREP AND THE EXCESS NUPREP WAS WIPED OFF. THE SITE WAS COVERED WITH DERMACEA STRETCH BANDAGE AFTER THE LEADS WERE APPLIED. THE DAMAGED SKIN WAS TREATED WITH SILVADINE AND THE AREAS HEALED NICELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CFM MODEL 6000 HYDROGEL ELECTRODES AEEG ELECTRODES, HYDROGEL GWQ NATUS MEDICAL INCORPORATED NA 906104

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CONNECTED TO AN ECG AND| PULSE OXIMETER.| INFANT WAS ON PHENOBARBITAL DURING THE TWO DAYS &| ALSO WAS BENEATH A RADIANT WARMER AND