BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FENIX CONTINENCE RESTRORATION SYSTEM

    MDR report key: 6116684 · Received November 21, 2016

    Report

    Report Number
    3008766073-2016-00092
    Event Type
    Injury
    Date Received
    November 21, 2016
    Report Date
    October 25, 2016
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    PMH
    UDI-DI
    00855106005530
    PMA / PMN Number
    H130006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOWING A SURGICAL PROCEDURE FOR REINFORCEMENT OF THE ANAL SPHINCTER DUE TO FECAL INCONTINENCE, A PATIENT EXPERIENCED DEHISCENCE OF THE SURGICAL WOUND LEADING TO INFECTION AND THEN TO FENIX DEVICE EXPLANT. THE FENIX DEVICE WAS USED AS PART OF THE SURGICAL PROCEDURE. SURGICAL PROCEDURE AND DEVICE IMPLANT ON (B)(6) 2016. PATIENT EXPERIENCE CONSTIPATION IN THE FIRST WEEK AFTER IMPLANT AND WAS PRESCRIBED LAXATIVES. THE PATIENT THEN EXPERIENCED DIARRHEA BUT THEN HER STOOL CONSISTENCY LEVELED OUT. THE PATIENT CONSULTED HER PHYSICIAN REGARDING WOUND DRAINAGE AND WAS ADMITTED TO THE HOSPITAL. THE SURGICAL WOUND WAS INSPECTED AND FOUND TO BE 50% OPEN BUT NOT RED NOR PURULENT. EXAMINATION SHOWED THE DEEPER SUTURE WERE STILL INTACT WITH NO EXPOSURE OF THE DEVICE. THE PATIENT WAS TREATED WITH IV ANTIBIOTICS (OFLOXACIN/ZOCIN). PATIENT REPORTED THAT SHE WAS ABLE TO HOLD HER BOWELS. PATIENT WAS REEXAMINED ON (B)(6) 2016 AND THE PHYSICIAN NOTED THAT THE WOUND HAD OPENED UP A "LITTLE BIT MORE" BUT HAD STABILIZED ON (B)(6) 2016 AND DISCHARGED ON (B)(6) 2016 DEVICE EXPLANT THROUGH SURGICAL SITE ON (B)(6) 2016 DUE TO INFECTION. DEVICE WAS FOUND CORRECT POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767511 FENIX CONTINENCE RESTRORATION SYSTEM IMPLANTED FECAL INCONTINENCE DEVICE PMH TORAX MEDICAL, INC. FXS20 10526 00855106005530

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| O