BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAHESIVE. WFR W/NATURA FLG

    MDR report key: 5289413 · Received December 11, 2015

    Report

    Report Number
    9618003-2015-40074
    Event Type
    Injury
    Date Received
    December 11, 2015
    Date of Event
    July 9, 2012
    Report Date
    November 6, 2015
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC, INC
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF ACTIVITIES RELATED TO (B)(4). CONVATEC IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21CFR PART 803. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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

    COMPLAINANT REPORTS "THAT WHEN HE REMOVED THE SKIN BARRIER YESTERDAY IT WAS DIFFICULT TO REMOVE. HE STATES THAT THE TEMPERATURES WERE VERY HIGH AND THAT THE BARRIER MAY HAVE BEEN AFFECTED BY THAT AND SEEMED A BIT MELTED. HE STATES THAT HE PULLED THE SKIN OFF AT ABOUT 2 OCLOCK AT ABOUT THE POSITION WHERE THE FLANGE IS LOCATED LEAVING A WOUND THAT WAS ABOUT 25 MM X 3 MM X 2 MM. IT DID BLEED SLIGHTLY. REPORTS CLEANSING SKIN AS USUAL AND REAPPLIED APPLIANCE NO OTHER TREATMENT WAS DONE HE DOES NOT USE ADHESIVE REMOVER OR PROTECTIVE BARRIER WIPES OR STOMAHESIVE POWDER." DISCUSSED USE OF THESE PRODUCTS TO AVOID SKIN INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819692 DURAHESIVE. WFR W/NATURA FLG PROTECTOR, OSTOMY EXE CONVATEC DOMINICAN REPUBLIC, INC 401905 2A01894

    Patients

    Seq Age Sex Outcome Treatment
    1