BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURA 2 PC - DURAHESIVE CONVEX MOLDABLE WAFER

    MDR report key: 3950990 · Received July 14, 2014

    Report

    Report Number
    1049092-2014-00293
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    EXE
    PMA / PMN Number
    K855018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. FURTHER CLARIFICATION IN REGARDS TO WHETHER NYSTATIN POWDER USED WAS AN OVER THE COUNTER (OTC) OR A PRESCRIPTION MEDICATION WAS NOT AVAILABLE. IN ADDITION, PRODUCT WEAR TIME IS UNKNOWN, AND PATIENT PLANS TO FOLLOW-UP WITH LOCAL WOULD NURSE SOON TO DISCUSS ALTERNATE PRODUCTS. LASTLY, IT IS REPORTED THAT PATIENT HAS TRIED A HIGH OUTPUT POUCH IN PAST BUT DECLINES TO USE IT NOW. 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 EVENT IS UNK, 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 THE PATIENT, WHO RESIDES IN A NURSING HOME AND IS BEING ADMINISTERED NUTRITION VIA A GASTROSTOMY TUBE (G TUBE), PRESENTED WITH REDNESS TO THE SKIN LOCATED UNDER MASS AND TAPE COLLAR RELATED TO LEAKAGE FROM THE OSTOMY POUCH. IT IS FURTHER REPORTED THAT THE LEAKAGE IS POSSIBLY RELATED TO THE POUCH BEING ROLLED UP UNDERNEATH PATIENT WHEN REPOSITIONED FROM SIDE TO SIDE BY THE NURSING STAFF. LASTLY, TREATMENT FOR THIS ISSUE WAS PROVIDED WITH NYSTATIN OR STOMAHESIVE POWDER, AND CAVILON PROTECTIVE BARRIER SPRAY TO SKIN AS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410118 NATURA 2 PC - DURAHESIVE CONVEX MOLDABLE WAFER PROTECTOR, OSTOMY EXE CONVATEC INC. 404593 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention