BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUR-FIT NATURA 2PC DURAHESIVE CONVEX MODABLE

    MDR report key: 3546735 · Received December 20, 2013

    Report

    Report Number
    1049092-2013-00378
    Event Type
    Injury
    Date Received
    December 20, 2013
    Date of Event
    October 21, 2013
    Report Date
    November 22, 2013
    Manufacturer
    CONVATEC INC
    Product Code
    EXB
    PMA / PMN Number
    K855018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A SERIOUS INJURY. END USER REPORTED SHE USES EAKIN COHESIVE SLIMS UNDER HER SKIN BARRIER. SHE CLEANSES HER PERISTOMAL SKIN DOVE SOAP AND APPLIES STOMAHESIVE POWDER; FOLLOWED BY 3M NO STING BARRIER FILM TO THE REDDENED AREA. END USER WAS INSTRUCTED ON USING SOAP THAT DOES NOT CONTAIN LOTIONS; MOISTURIZERS OR CREAMS AND WAS RECOMMEND A SMALLER MOLDABLE DH CONVEX SKIN BARRIER. NO ADDITIONAL PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON (B)(4) 2013.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2015. THE PRODUCT ASSOCIATED WITH LOT# 2K03255 WAS MANUFACTURED ACCORDING TO SPECIFICATION. AFTER A THOROUGH BATCH REVIEW, NO DISCREPANCIES, NON-CONFORMANCES OR DEVIATIONS WERE FOUND. THERE IS NOT ENOUGH INFORMATION TO CONCLUDE THE PRODUCT DID NOT MEET SPECIFICATION AND PERFORM AS INTENDED. PRODUCT MONITORING REVIEWS WILL MONITOR FOR PRODUCT TRENDS IF THIS ISSUE WERE TO REOCCUR. PREVIOUS INVESTIGATION, IS APPLICABLE TO THIS COMPLAINT INVESTIGATION. THEREFORE, THIS COMPLAINT WILL REMAIN OPEN UNTIL COMPLETION OF THE PREVIOUS INVESTIGATION. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    END USER REPORTED CIRCUMFERENTIAL REDNESS TO HER PERISTOMAL SKIN WHICH EXTENDS OUTWARD THE FURTHEST AT THE DISTAL END APPROXIMATELY 13MM. SHE DOES EXPERIENCE BURNING AND PAIN FROM THIS AREA. SHE DEVELOPED THIS REDNESS AFTER HER STOMA WAS REVISED FROM A COLOSTOMY TO AN ILEOSTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669207 SUR-FIT NATURA 2PC DURAHESIVE CONVEX MODABLE PROTECTOR, OSTOMY EXB CONVATEC INC 404593 2K03255

    Patients

    Seq Age Sex Outcome Treatment
    1