BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODERMA FLEX CONVEX FLEXTEND TRANSPARENT UROSTOMY 25 MM CUT TO FIT POUCH

    MDR report key: 3891646 · Received June 24, 2014

    Report

    Report Number
    1119193-2014-00015
    Event Type
    Injury
    Date Received
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    EXB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THE SKIN REACTION CAN NOT BE DETERMINED. A COMPLAINT TREND ANALYSIS WAS REVIEWED FROM JAN 2011 THROUGH MAY 2014 AND NO ADVERSE TRENDS WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A SKIN REACTION WHILE USING THE MODERMA FLEX CONVEX CUT TO FIT UROSTOMY POUCH WITH FLEXTEND BARRIER AND ADHESIVE BORDER. THE PATIENT HAD BEEN USING THE PRODUCT FOR ABOUT A YEAR PRIOR TO HAVING A REACTION. IT WAS UNKNOWN HOW LONG THE SPECIFIC BARRIER WAS IN USE AT THE TIME OF THE REACTION. THREE ROUNDS OF ORAL ANTIBIOTICS ( TWO ROUNDS OF FLUCLOXICILLIN, ONE ROUND OF CO-AMOXICLAV) WERE PRESCRIBED FOR THE PATIENT ALONG WITH SKIN OINTMENT. THE PATIENT IS NOW USING A DIFFERENT POUCHING SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368543 MODERMA FLEX CONVEX FLEXTEND TRANSPARENT UROSTOMY 25 MM CUT TO FIT POUCH OSTOMY EXB HOLLISTER INCORPORATED 29700

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention