BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUR-FIT NATURA 2 PC DURAHESIVE CONVEX MOLDABLE

    MDR report key: 3936077 · Received June 23, 2014

    Report

    Report Number
    1049092-2014-00234
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    CONVATEC, INC
    Product Code
    EXE
    PMA / PMN Number
    K855018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. SKIN CARE ROUTINE AND APPLICATION OF STOMAHESIVE POWDER AND ANTI FUNGAL POWDERS WERE REVIEWED. WITH END-USER'S SON. IT WAS SUGGESTED THAT HE CONTACT A HEALTH CARE PROVIDER (HCP) AND TO REQUEST AN ANTI-FUNGAL POWDER. LASTLY, HE WAS ADVISED TO NOTIFY CONVATEC AFTER SPEAKING WITH HIS SISTER IN REGARDS TO THE WAFER FIT. NO ADD'L PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVAL IS NOT EXPECTED. SHOULD ADD'L INFO BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. (B)(4). NOTE: THE ACTUAL DATE OF EVENT IS UNK, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE . CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC INC'S. COMPLAINT HANDLING AND CAPA PROCEDURES.

    Description of Event or Problem · 1

    IT IS REPORTED THAT END-USER DEVELOPED A RASH WITH REDNESS ON THE LEFT ABDOMINAL SKIN BENEATH THE WAFER APPROX TWO AND A HALF (2 1/2) MONTHS AGO. THE ISSUE STARTED AS A RASH AND NOW THERE ARE TWO (2) AREAS ON RAWNESS THAT ARE WEEPY SO THE WAFER DOES NOT ADHERE WELL. IT IS UNCERTAIN IF THERE IS STILL LEAKING BENEATH THE WAFER OF WHETHER THE WAFER FIT PROPERLY OR NOT. PLEASE NOTE THAT THIS INFO WAS PROVIDED BY SON OF END-USER WHO HAD LIMITED DETAILS, AS HE DOES NOT PROVIDED DIRECT CARE TO HIS MOTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367345 SUR-FIT NATURA 2 PC DURAHESIVE CONVEX MOLDABLE PROTECTOR, OSTOMY EXE CONVATEC, INC 404594 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention