BEUDAMED
    FDA Adverse Event Other Summary report: N

    EPICERAM SKIN BARRIER REPAIR

    MDR report key: 1610831 · Received February 5, 2010

    Report

    Report Number
    3006279883-2010-00002
    Event Type
    Other
    Date Received
    February 5, 2010
    Date of Event
    October 28, 2009
    Report Date
    November 4, 2009
    Manufacturer
    CERAGENIX PHARMACEUTICALS, INC.
    Product Code
    FRO
    PMA / PMN Number
    K052643
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CERAGENIX HAS RECENTLY RE-EVALUATED THE MDR REVIEW PROCESS AND DETERMINED THAT THIS EVENT IS REPORTABLE UNDER REGULATION.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM DISTRIBUTOR, PROMIUS PHARMA ON 11/04/2009. THE PROMIUS REPORT INDICATED THAT A WOMAN OF UNKNOWN AGE SPONTANEOUSLY REPORTED THAT SHE DEVELOPED A RASH AFTER APPLYING EPICERAM. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS ARE UNKNOWN. ON (B)(6) 2009, THE PATIENT OBTAINED EPICERAM SKIN BARRIER EMULSION, LOT # 24379154, FROM A PHARMACY. THE PATIENT INDICATED THAT THE PRODUCT WAS PRESCRIBED FOR TREATMENT OF INFLAMMATION ON A SPOT BELOW HER RIGHT EYE. DOSING INSTRUCTIONS INDICATE "APPLY TO AFFECTED AREA OF LOWER EYELIDS AS DIRECTED." ON (B)(6) 2009, THE PATIENT NOTICED A RASH AT THE APPLICATION SITE. THE PATIENT VISITED HER DERMATOLOGIST AND WAS GIVEN A LOCAL STEROID INJECTION (UNK MEDICATION) AND PRESCRIBED PROTOPIC (TACROLIMUS) FOR TREATMENT. SHE INDICATED THAT AFTER A FEW DAYS OF TREATMENT, THE RASH RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPICERAM SKIN BARRIER REPAIR UNCLASSIFIED FRO CERAGENIX PHARMACEUTICALS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other NO OTHER PRODUCTS REPORTED TO USED PRIOR TO EVENT.