BEUDAMED
    FDA Adverse Event Summary report: N

    NATUS JELLY TAB SENSORS

    MDR report key: 2472124 · Received February 26, 2012

    Report

    Report Number
    2472124
    Date Received
    February 26, 2012
    Date of Event
    January 23, 2012
    Report Date
    February 24, 2012
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    GWJ
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UPON REMOVING ABR (AUDITORY BRAINSTEM RESPONSE) PATCHES, PATIENT'S SKIN WAS NOTED TO BE RED AND TRAUMATIZED ON THE RIGHT FOREHEAD AND ANTERIOR LEFT EAR. UPON REMOVING BONE CONDUCTOR TRANSDUCER, PATIENT'S SKIN WAS NOTED TO APPEAR TRAUMATIZED ON POSTERIOR LEFT EAR. SURGEON NOTIFIED. AREA ASSESSED. PLASTIC SURGEON NOTIFIED AND AREA ASSESSED.SURGEON PLANS TO RE-ASSESS AT POST OPERATIVE APPOINTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATUS JELLY TAB SENSORS ELECTRODE, INFANT HEARING SCREENER GWJ NATUS MEDICAL INCORPORATED * N080311-03

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO