BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONVATEC ACCESSORIES-STOMAHESIVE PASTE/POWDER

    MDR report key: 3954826 · Received July 18, 2014

    Report

    Report Number
    1049092-2014-00328
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    CONVATEC, INC
    Product Code
    EXE
    PMA / PMN Number
    K803100
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. IT IS FURTHER REPORTED THAT THE TREATING PHYSICIAN HAS ASKED THE PRODUCERS (CONVATEC) FOR THE COMPOSITION OF THE OSTOMY PRODUCTS (STOMAHESIVE PASTE) USED WHICH WAS SENT TO HER VIA EMAIL. 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. 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 OSTOMY PATIENT SINCE THE AGE OF ONE WHO APPLIED PRODUCT AROUND STOMA, WENT TO THE HOSPITAL RELATED TO A PERISTOMAL CONTACT "ECZEMA" DESCRIBED AS A LITTLE BUT LARGER THAN THE USED WAFER (NON CONVATEC PRODUCT). IT IS FURTHER REPORTED THAT A PATCH TEST REVEALED A SENSITIZATION ASSOCIATED WITH THE CHEMICAL SUBSTANCE, BUTYL GLYCIDYL ETHER. LASTLY, PATIENT WAS PROVIDED TREATED WITH A TOPICAL STEROID THERAPY WHICH COMPLETELY HEALED PATIENT'S "ECZEMA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422459 CONVATEC ACCESSORIES-STOMAHESIVE PASTE/POWDER PROTECTOR, OSTOMY EXE CONVATEC, INC 183910 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention