BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPICERAM SKIN BARRIER EMULSION

    MDR report key: 1653587 · Received April 2, 2010

    Report

    Report Number
    MW5015465
    Event Type
    Injury
    Date Received
    April 2, 2010
    Date of Event
    March 26, 2010
    Report Date
    April 2, 2010
    Manufacturer
    PROMIUS PHARMA
    Product Code
    MGQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MY SON'S DOCTOR PRESCRIBED THE USE OF "EPI-CERAM" TO BE APPLIED ALL OVER HIS SKIN IN ORDER TO ALLEVIATE HIS ECZEMA. AFTER SEVERAL DAYS OF APPLICATION, MY SON WAS COVERED IN CONTACT DERMATITIS, CAUSED BY AN ALLERGY TO THE "EPI-CERAM". DOSE OR AMOUNT: APPLIED TO SKIN ALL OVER, FREQUENCY: ONCE PER DAY, ROUTE: TOP. DATES OF USE: (B) (6) 2010 - (B) (6) 2010. DIAGNOSIS OR REASON FOR USE: ECZEMA. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPICERAM SKIN BARRIER EMULSION MGQ PROMIUS PHARMA 25344177

    Patients

    Seq Age Sex Outcome Treatment
    1 16 MO Other