BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUR-FIT NATURA STOMAHESIVE FLEXIBLE SKIN BARRIER W/FLANGE W/TAPE COLLAR & CUT-TO

    MDR report key: 4100853 · Received September 12, 2014

    Report

    Report Number
    1049092-2014-11110
    Event Type
    Injury
    Date Received
    September 12, 2014
    Report Date
    November 27, 2012
    Manufacturer
    CONVATEC, INC.
    Product Code
    EXE
    PMA / PMN Number
    K830945
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS IS TAKEN FROM A TRENDING REPORT OF EVALUATIONS OR ADVERSE EVENTS FINALIZED MAY 2011. THE DATA PRESENTED IS FROM THREE DIFFERENT PRODUCT APPLICATIONS. THE REPORT STATES THAT THERE ARE NO SIGNIFICANT TRENDS. CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO THE FDA 483 ISSUED 04/16/2014. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. BRAND NAME: SUR-FIT NATURA STOMAHESIVE FLEXIBLE SKIN BARRIER W/ FLANGE W/TAN TAPE COLLAR AND CUT-TO-FIT OPENING.

    Description of Event or Problem · 1

    THE PATIENT REPORTED SHE DEVELOPED REDNESS AND BURNING UNDER TAPE COLLAR OF THE DEVICE AFTER A FEW HOURS OF USE. THE PATIENT INCORPORATED A PROTECTIVE STOMA POWDER INTO HER APPLICATION PROCESS, HOWEVER, SHE HAS SEEN NO IMPROVEMENT. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565134 SUR-FIT NATURA STOMAHESIVE FLEXIBLE SKIN BARRIER W/FLANGE W/TAPE COLLAR & CUT-TO PROTECTOR, OSTOMY EXE CONVATEC, INC. 125264

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other