BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUR-FIT NATURA DURAHESIVE FLEXIBLE SKIN BARRIER W/FLANGE W/WHITE TAPE COLLAR & C

    MDR report key: 4100833 · Received September 12, 2014

    Report

    Report Number
    9618003-2014-11086
    Event Type
    Injury
    Date Received
    September 12, 2014
    Report Date
    November 15, 2012
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC, INC.
    Product Code
    EXE
    PMA / PMN Number
    K855018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. SUR-FIT NATURA DURAHESIVE FLEXIBLE SKIN BARRIER W/FLANGE W/WHITE TAPE COLLAR & CUT-TO-FIT OPENING.

    Description of Event or Problem · 1

    THE PATIENT REPORTED SHE DEVELOPED A RASH UNDER THE TAPE COLLAR OF THE DEVICE. THE DURATION OF THE RASH IS UNKNOWN. THE PATIENT REPORTEDLY CHANGES HER DEVICE EVERY 4-5 DAYS. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565053 SUR-FIT NATURA DURAHESIVE FLEXIBLE SKIN BARRIER W/FLANGE W/WHITE TAPE COLLAR & C PROTECTOR, OSTOMY EXE CONVATEC DOMINICAN REPUBLIC, INC. 413163

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other