BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEW IMAGE CERAPLUS SKIN BARRIER WITH TAPE BORDER

    MDR report key: 9250812 · Received October 29, 2019

    Report

    Report Number
    1119193-2019-00039
    Event Type
    Injury
    Date Received
    October 29, 2019
    Date of Event
    March 26, 2019
    Report Date
    October 29, 2019
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    EXB
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BIOCOMPATIBILITY TESTING HAS BEEN PERFORMED IN ACCORDANCE WITH ISO 10993 AND MATERIALS WERE FOUND TO BE NON-SENSITIZERS. DHR REVIEW NOT POSSIBLE BECAUSE NOT NUMBER NOT KNOWN. SAMPLE REVIEW NOT POSSIBLE BECAUSE NO SAMPLE AVAILABLE. TREND DATA REVIEWED AND NO ADVERSE TREND OBSERVED. THE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN END USER HAS HAD RED ITCHY BUMPS UNDER HER HOLLISTER OSTOMY BARRIER SINCE (B)(6) OF 2019. SHE SAW HER DOCTORS WHO PRESCRIBED HYDROCORTISONE 2.5% FOR THE ITCHING AND NYSTOP ANTIFUNGAL TOPICAL POWDER. HER SKIN CONTINUES TO BE RED AND ITCHY AT TIMES. SHE CONTINUES TO USE THE MEDICINES AS NEEDED. SHE IS SCHEDULED FOR A STOMA REVERSAL AT THE BEGINNING OF NOVEMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045041 NEW IMAGE CERAPLUS SKIN BARRIER WITH TAPE BORDER NEW IMAGE CERAPLUS SKIN BARRIER WITH TAPE BORDER EXB HOLLISTER INCORPORATED UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention