BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLILBAND

    MDR report key: 3599948 · Received January 24, 2014

    Report

    Report Number
    MW5034047
    Event Type
    Injury
    Date Received
    January 24, 2014
    Date of Event
    January 6, 2014
    Report Date
    January 13, 2014
    Manufacturer
    NATUS MEDICAL INC.
    Product Code
    FOK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NEWBORN WAS FOUND UNDER PHOTOTHERAPY WITH BILIBAND MASK ON WITHOUT THE PROTECTIVE EYE PADS UNDER THE STRAPS OF THE MASK. NEW BILL MASK OBTAINED. PEDIATRIC OPHTHALMOLOGIST FELT F/U VISIT AFTER D/C WOULD SUFFICE. MANUFACTURER: PLEASE NOTE THAT WE DO NOT SEND PRODUCTS TO THE MANUFACTURER, BUT YOU MAY ARRANGE FOR PICK-UP BY CALLING MY NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56235 BLILBAND NATUS BILIBAND FOK NATUS MEDICAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA Required Intervention