BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUR-FIT NATURA 2 PC-DURAHESIVE CONVEX WAFER

    MDR report key: 4203081 · Received October 23, 2014

    Report

    Report Number
    1049092-2014-00563
    Event Type
    Injury
    Date Received
    October 23, 2014
    Date of Event
    September 24, 2014
    Report Date
    October 21, 2014
    Manufacturer
    CONVATEC, INC.
    Product Code
    EXE
    PMA / PMN Number
    K855018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED NOVEMBER 17, 2015. THE PRODUCT ASSOCIATED WITH BATCH 2G01564 WAS MADE ACCORDING TO SPECIFICATION. NO PREVIOUS INVESTIGATIONS ARE AVAILABLE. AFTER DETAILED BATCH REVIEW, NO DISCREPANCIES (INCLUDES NON-CONFORMANCES/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. NO FURTHER ACTIONS ARE REQUIRED, AND THE COMPLAINT WILL BE CLOSED. NO ADDITIONAL EVENT INFORMATION AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. END USE REPORTS USING STOMAHESIVE POWDER AND PROTECTOR BARRIER WIPES, AND STOMAHESIVE STRIPS. ALSO REPORTS TRYING COLOPLAST WAFERS. END USE WAS REFERRED TO PHYSICIAN. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT IS REPORTED BY THE END USER OF AN OPEN AREA TO PERISTOMAL SKIN AT ONE O'CLOCK AREA THAT MEASURES APPROXIMATELY ONE INCH AND DRAINS CLEAR TO BLOOD FLUID. PER THE END USER, THIS WAS ORIGINALLY WHERE THE LOOP ROD WAS. THERE WAS A LITTLE SCAB AFTER THE ROD WAS REMOVED THAT HAS GROWN INTO THIS ONE INCH OPEN AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676078 SUR-FIT NATURA 2 PC-DURAHESIVE CONVEX WAFER PROTECTOR, OSTOMY EXE CONVATEC, INC. 413188 2G01564

    Patients

    Seq Age Sex Outcome Treatment
    1