BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURA 2 PC- DURAHESIVE MOLDABLE WAFER

    MDR report key: 3667060 · Received February 12, 2014

    Report

    Report Number
    1049092-2014-00050
    Event Type
    Injury
    Date Received
    February 12, 2014
    Date of Event
    January 22, 2014
    Report Date
    January 22, 2014
    Manufacturer
    CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C.
    Product Code
    EXE
    PMA / PMN Number
    K855018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON 08/07/2015 CONFIRMING THAT THE LOT # IS INVALID. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON 08/12/2015.

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A SERIOUS INJURY. IT IS REPORTED THAT END-USER VISITED AN OSTOMY NURSE WHO PRESCRIBED (B)(4) POWDER WHICH HE APPLIED EVERY FIVE DAYS AT WAFER CHANGE, BUT HAS NOT SEEN MUCH IMPROVEMENT AS A RESULT. END -USER WAS INSTRUCTED TO CHANGE THE WAFER MORE OFTEN IN ORDER TO APPLY THE (B)(4) POWDER. END-USER WAS ALSO INSTRUCTED THAT THE WAFER'S OPENING IS TOO LARGE FOR STOMA. SAMPLES OF SMALLER SIZE WILL BE SENT TO END-USER. CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO IT'S COMPLAINT HANDLING AND CAPA PROCEDURES. NO ADD'L PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVAL IS NOT EXPECTED. SHOULD ADD'L INFO BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4). NOTE THE ACTUAL DATE OF EVENT IS UNK, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE.

    Description of Event or Problem · 1

    END-USER REPORTED THAT A MONTH AGO, THE AREA AROUND THE STOMA (RIGHT SIDE OF ABDOMEN) PRESENTED WITH RED DOTS AND ITCHING, WHICH HAS BECOME MORE INFLAMED OVER TIME. IT IS REPORTED THAT AFFECTED SITE SHOWED SIGNS OF BLEEDING AT THE TIME OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92877 NATURA 2 PC- DURAHESIVE MOLDABLE WAFER PROTECTOR, OSTOMY EXE CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C. 411802 CNO

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention