BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXI-SEAL FECAL MANAGEMENT KIT

    MDR report key: 5606142 · Received April 25, 2016

    Report

    Report Number
    1049092-2016-00187
    Event Type
    Death
    Date Received
    April 25, 2016
    Report Date
    April 5, 2016
    Manufacturer
    CONVATEC INC.
    Product Code
    KNT
    PMA / PMN Number
    K112342
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. BASED ON AVAILABLE INFORMATION NO PRODUCT MALFUNCTION OCCURRED. NO LOT NUMBER OR PRODUCT EVALUATION SAMPLE IS AVAILABLE. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE THIS EVALUATION WILL BE CLOSED AND WILL BE MONITORED THROUGH OUR POST MARKET PRODUCT MONITORING REVIEW PROCESS. 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 APRIL 25, 2016. (B)(4). NOTE: ANOTHER CASE IS ASSOCIATED WITH THIS COMPLAINT. A SEPARATE 3500A FORM HAS BEEN COMPLETED FOR THE OTHER CASE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NURSE, THAT THE DEVICE HAD BEEN INSERTED AS A COMFORT MEASURE FOR A PATIENT IN THE END STAGES OF LIFE AND HAD MANY COMORBIDITIES. AFTER AN UNKNOWN AMOUNT OF TIME, THE PATIENT BEGAN TO EXPERIENCE "A LARGE AMOUNT" OF RECTAL AND VAGINAL BLEEDING. THE DEVICE WAS REMOVED AND THE PATIENT WAS FOUND TO HAVE DEVELOPED A FULL-THICKNESS EROSION OF THE RECTAL WALL. IT WAS ALSO REPORTED THAT THE PATIENT SUCCUMBED TO HER ILLNESS, BUT THE DATE, TIME, AND CAUSE OF DEATH WERE NOT PROVIDED. IT WAS STATED THAT THE DEVICE HAS BEEN DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258454 FLEXI-SEAL FECAL MANAGEMENT KIT GASTROINTESTINAL TUBE AND ACCESSORIES KNT CONVATEC INC. 418000

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death