BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUR-FIT NATURA 2PC DURAHESIVE CONVEX WAFER

    MDR report key: 3888032 · Received June 4, 2014

    Report

    Report Number
    1049092-2014-00163
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    CONVATEC, INC.
    Product Code
    EXE
    PMA / PMN Number
    K855018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. NURSE WAS PROVIDED INSTRUCTIONS IN THE USE OF AN ANTI-FUNGAL POWDER AND CRUSTING WITH NO STING PROTECTIVE BARRIER WIPES, AND TO NOTIFY CONVATEC WITH ANY QUESTIONS OR CONCERNS. IT IS REPORTED THAT THE NURSE WAS NOT AT THE END-USER'S HOME; THEREFORE, SHE WAS UNABLE TO PROVIDE THE LOT NUMBER FOR THIS PRODUCT. LASTLY, THE END USER WILL BE SENT SAMPLES OF THE CONVEX MOLDABLE ESTEEM SYNERGY TWO PIECE SYSTEM TO THE (ESTEEM SYNERGY (B)(4) MOLDABLE CONVEX SKIN BARRIER W/LANDING ZONE FLANGE W/WHITE TAPE COLLAR AND CUT-TO-FIT OPENING; AND ESTEEM SYNERGY UROSTOMY POUCH W/(B)(4) TAP W/VALVE STANDARD LENGTH, 10.3", TRANSPARENT W/1-SIDED COMFORT PANEL) ALONG WITH SENSI-CARE NO STING PROTECTIVE BARRIER WIPES. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. NOTE: THE ACTUAL DATE OF THE EVENT IS UNKNOWN, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE. CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC INC'S. COMPLAINT HANDLING AND CAPA PROCEDURES.

    Description of Event or Problem · 1

    IT IS REPORTED THAT END-USER DEVELOPED A FUNGAL RASH LOCATED AT THE RIGHT LOWER QUADRANT (RQL) UNDER BOTH THE MASS AND TAPE BORDER WHICH BEGAN APPROXIMATELY TWO (2) WEEKS AGO. TREATMENT AS PRESCRIBED BY A PHYSICIAN OF AN ORAL ANTI FUNGAL MEDICATION, AND NO TOPICAL TREATMENT WAS PRESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327934 SUR-FIT NATURA 2PC DURAHESIVE CONVEX WAFER PROTECTOR, OSTOMY EXE CONVATEC, INC. 413183 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention