BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAHESIVE. WFR W/NATURA FLG

    MDR report key: 5142506 · Received October 10, 2015

    Report

    Report Number
    1049092-2015-30397
    Event Type
    Injury
    Date Received
    October 10, 2015
    Date of Event
    December 31, 2013
    Report Date
    February 27, 2014
    Manufacturer
    CONVATEC, INC.
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF ACTIVITIES RELATED TO CONVATEC REMEDIATION PROTOCOL 2015-001-PRO AND PROTOCOL 2015-002-PRO. CONVATEC IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21CFR PART 803. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT WILL BE FILED ON A SUPPLEMENTAL REPORT (MEDWATCH 3500A).

    Description of Event or Problem · 1

    END USER HUSBAND IS HER CAREGIVER. END USER CAREGIVER REPORTS BLEEDING NOTED TO END USER PERISTOMAL SKIN UNDER THE WHITE TAPE COLLAR AT 7 OCLOCK WHICH MEASURES APPROXIMATELY THE SIZE OF A DIME OR LESS. HE REPORTS A VERY SMALL AMOUNT OF BLEEDING NOTED FROM THIS AREA. HE CAN SEE DRIED BLOOD UNDER THE WHITE TAPE COLLAR. INSTRUCTED ON CRUSTING WITH SH POWDER AND WATER OR PROTECTIVE BARRIER WIPES. INSTRUCTED ON CLEANSING END USER PERISTOMAL SKIN WITH SOAP THAT DOES NOT CONTAIN LOTIONS; MOISTURIZERS OR CREAMS. INSTRUCTED IF AREA WORSENS OR DOES NOT IMPROVE TO CALL BACK FOR ADDITIONAL INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673928 DURAHESIVE. WFR W/NATURA FLG PROTECTOR, OSTOMY EXE CONVATEC, INC. 413161 3G00277

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention