BEUDAMED
    FDA Adverse Event Other Summary report: N

    EPICERAM SKIN BARRIER EMULSION

    MDR report key: 1622865 · Received March 1, 2010

    Report

    Report Number
    3006279883-2010-00004
    Event Type
    Other
    Date Received
    March 1, 2010
    Date of Event
    January 6, 2010
    Report Date
    January 29, 2010
    Manufacturer
    CERAGENIX PHARMACEUTICALS, INC.
    Product Code
    FRO
    PMA / PMN Number
    K052643
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT COLLECTED DATA INDICATES THAT PRODUCT IS WITHIN SPECIFICATIONS AND MAY NOT MEET MDR CRITERIA. HOWEVER, AS ALL TEST RESULTS HAVE NOT BEEN COMPLETED AT THE TIME OF MDR SUBMISSION, A DECISION WAS MADE BY MANUFACTURER TO SUBMIT AS A PRECAUTION. A F/U REPORT WILL BE FILED WITH ADD'L INFO AS APPLICABLE.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM DISTRIBUTOR (B)(6) 2010. APPROXIMATELY TWO WEEKS BEFORE REPORT DATE THE REPORTER PURCHASED ONE TUBE OF EPICERAM FROM A (B)(6). ABOUT THE SAME TIME, PT STARTED USING THE PRODUCT TWICE DAILY TO BACK AND CHEST FOR TREATMENT OF ECZEMA. INITIAL REPORT INDICATED A WEEK (LATER REPORT THE REPORTER INDICATED 3-4 DAYS) LATER, THE PT POINTED OUT TO REPORTER THAT THE AREAS WHERE THE PRODUCT WAS BEING APPLIED WERE REDDENING SIGNIFICANTLY. THE PT STOPPED USING EPICREAM AND THE REPORTER TOOK PT TO THEIR PHYSICIAN. PHYSICIAN SWITCHED THE PT'S THERAPY TO LOCOID CREAM (UNK STRENGTH OR DOSAGE.) PT IS RESPONDING WELL TO NEW THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPICERAM SKIN BARRIER EMULSION NONE FRO CERAGENIX PHARMACEUTICALS, INC. 24838155

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other NO CONCOMITANT PRODUCTS REPORTED.