BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S4S/SURIFIT NATURA 2PC-2PC DURAHESIVE (DH)

    MDR report key: 4023514 · Received August 13, 2014

    Report

    Report Number
    1049092-2014-10807
    Event Type
    Injury
    Date Received
    August 13, 2014
    Report Date
    July 13, 2012
    Manufacturer
    CONVATECH 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

    CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO THE FDA 483 ISSUED APRIL 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. 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.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE END USER STATES THAT THEY DEVELOPED A CIRCUMFERENTIAL RED RASH UNDER THE HYDROCOLLOID TAPE COLLAR OF HER SKIN BARRIER. THE END USER DOES EXPERIENCE ITCHING FROM THE AREA. SHE CHANGES HER SKIN BARRIER EVERY 2-7 DAYS. SHE USES AN OSTOMY POWDER AND SKIN PROTECTIVE BARRIER WIPES TO THE RED RASH LIKE AREA. SHE HAD BEEN USING ANTIFUNGAL POWDER TO THE RED RASH LIKE AREA BUT HER PROFESSIONAL HEALTH CARE PROVIDER DID NOT FEEL IT WAS FUNGAL AND INSTRUCTED THE END USER TO START USING THE SH POWDER. THE PATIENT'S SUBSEQUENT OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483117 S4S/SURIFIT NATURA 2PC-2PC DURAHESIVE (DH) PROTECTOR, OSTOMY EXE CONVATECH INC. 411800 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention