BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEROYAL

    MDR report key: 3142246 · Received May 24, 2013

    Report

    Report Number
    3005225477-2013-00008
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    DEROYAL GUATEMALA
    Product Code
    FOK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    SA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE HAS BEEN RETURNED TO DEROYAL FOR EVAL. THERE HAVE BEEN NO ADD'L COMPLAINTS FOR THIS PART NUMBER. THE INVESTIGATION INTO THE ROOT CAUSE HAS NOT BEEN COMPLETED AT THIS TIME.

    Description of Event or Problem · 1

    THE MEDICAL CENTER REPORTED THAT THE NEONATAL EYE COVERS WERE CAUSING RED IRRITATION ON THE BABIES IN THE ELASTIC AREA OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231949 DEROYAL FOK - PAD, NEONATAL EEY FOK DEROYAL GUATEMALA 24569859

    Patients

    Seq Age Sex Outcome Treatment
    1 Other