BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURA 2 PC - STOMAHESIVE WAFER W/FLEX COLLAR

    MDR report key: 3960339 · Received July 17, 2014

    Report

    Report Number
    1049092-2014-00309
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    January 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    CONVATEC INC
    Product Code
    EXE
    PMA / PMN Number
    K830945
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. IT IS REPORTED THAT SKINCARE WAS REVIEWED AND STOMA ASSESSMENT COMPLETED, AND THE FOLLOWING PRODUCTS ARE USED FOR CLEANSING SKIN: USES (B)(4) SOAP; SKIN INTEGRITY WOUND CLEANSER AND OCCASIONAL STOMAHESIVE POWDER. IT IS FURTHER REPORTED THAT END-USER TAPES LOWER BORDER OF WAFER WITH (B)(4) TAPE; DISCUSSED NEED FOR CONVEXITY; CRUSTING TECHNIQUES WERE REVIEWED, AND LASTLY END-USER WAS ADVISED TO STOP USING (B)(4) SOAP AND WOUND CLEANSER, BUT TO USE A MILD SOAP (B)(4) FOR CLEANSING SKIN. END-USER HAS (B)(4) WIPES; SENDING SAMPLES, AND WILL NOTIFY CONVATEC IF CONDITION PERSISTS. NO ADD'L PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVAL IS NOT EXPECTED. SHOULD ADD'L INFO BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON (B)(4) 2014. (B)(4). 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 THE END-USER WITH A SIX (6) MONTH HISTORY OF A RASH LOCATED UNDER THE OSTOMY TAPE BORDER SOUGHT TREATMENT FROM A DERMATOLOGIST WHO ADMINISTERED A PRESCRIPTION CREAM, WHICH END-USER IS APPLYING ONLY AT NIGHTS. IT IS FURTHER REPORTED THAT PRODUCT WEAR TIME IS ONLY TWO (2) DAYS AND THAT TAPING AND HEAT CAUSED RASH AND URINE LEAKS UNDER WAFER. LASTLY, REPORT STATES THAT END-USER SAW A DERMATOLOGIST ON (B)(6) 2014 WHO STARTED END-USER ON FLUOCINONIDE CREAM AND WAS ADVISED TO START APPLYING AN OVER THE COUNTER (OTC) ANTIFUNGAL POWDER UNDER POUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420389 NATURA 2 PC - STOMAHESIVE WAFER W/FLEX COLLAR PROTECTOR, OSTOMY EXE CONVATEC INC 125262 3M01182

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention