BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXYALERT NIRSENSOR INFANT

    MDR report key: 4143397 · Received August 7, 2014

    Report

    Report Number
    8020893-2014-01958
    Event Type
    Injury
    Date Received
    August 7, 2014
    Date of Event
    June 19, 2014
    Report Date
    July 9, 2014
    Manufacturer
    COVIDIEN
    Product Code
    MUD
    PMA / PMN Number
    K091224
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COVIDIEN HAS ATTEMPTED TO GATHER FURTHER DETAILS SURROUNDING THE CIRCUMSTANCES OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENT REPORT MAY BE FILED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED: RN NOTICED SMALL RED LINE UNDER TRANSPARENT (ADHESIVE SURROUNDING CEREBRAL NIRS) ON RIGHT SIDE. RN PULLED NIRS BACK TO INVESTIGATE AND THE PATIENT APPEARED TO BE IN PAIN. RN NOTICED BLACK ON THE SKIN AND IMMEDIATELY BROUGHT CHARGE NURSE TO BEDSIDE. NIRS PROBE REMOVED AND OVAL SHAPED DARK PURPLE TO BLACK WOUND WITH SQUARE INDENTATION FROM NIRS LIGHT WAS DISCOVERED. PHYSICIAN BROUGHT TO BEDSIDE TO ASSESS. PATIENT EVALUATED BY WOUND CARE AND PLASTIC SURGERY FOR APPROPRIATE TREATMENT. WOUND WAS LEFT OPEN TO AIR. DERMAGEL (ELASTO-GEL) DRESSING WAS PLACED THE FOLLOWING DAY, OLD BLOODY DRAINAGE ON EDGE OF LESION AS BLISTER HAD LOOSENED. WOUND IS BEING TREATED WITH ELASTOGEL DRESSING EVERY 3-5 DAYS AND WOUND CARE FOLLOWING PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464227 OXYALERT NIRSENSOR INFANT CEREBRAL SENSOR MUD COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO Required Intervention