BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 4100836 · Received September 12, 2014

    Report

    Report Number
    1049092-2014-11070
    Event Type
    Injury
    Date Received
    September 12, 2014
    Report Date
    November 12, 2012
    Manufacturer
    CONVATEC INC.
    Product Code
    EXE
    PMA / PMN Number
    K830945
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    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. DEVICE NAME: SUR-FIT NATURA STOMAHESIVE FLEXIBLE SKIN BARRIER W/FLANGE W/TAPE COLLAR AND CUT-TO-FIT OPENING.

    Description of Event or Problem · 1

    THE PATIENT REPORTED HE DEVELOPED A RED, IRRITATED AREA UNDER THE TAPE COLLAR OF THE DEVICE. THE IRRITATED AREA HAS PERSISTED FOR THREE MONTHS WITH NO IMPROVEMENT. THE PATIENT FURTHER INDICATED HE HAS USED THE SAME BRAND OF PRODUCT FOR THE LAST 20 YEARS. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565054 SUR-FIT NATURA STOMAHESIVE FLEXIBLE SKIN BARRIER W/ FLANGE W/TAPE COLLAR & CUT-T PROTECTOR, OSTOMY EXE CONVATEC INC. 125264

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other