BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FENIX CONTINENCE RESTRORATION SYSTEM

    MDR report key: 6116685 · Received November 21, 2016

    Report

    Report Number
    3008766073-2016-00093
    Event Type
    Injury
    Date Received
    November 21, 2016
    Date of Event
    October 26, 2016
    Report Date
    November 29, 2016
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    PMH
    PMA / PMN Number
    H130006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITION TO INCLUDE PATIENT STATUS AFTER REMOVAL (INFECTION HEALED AND PATIENT EXPERIENCING FI SYMPTOMS WORSE THAN PRE-IMPLANT).

    Description of Event or Problem · 1

    FOLLOWING A SURGICAL PROCEDURE FOR REINFORCEMENT OF THE ANAL SPHINCTER DUE TO FECAL INCONTINENCE, A PATIENT EXPERIENCED AN INFECTION AND RELATED PAIN LEADING TO FENIX DEVICE EXPLANT. THE FENIX DEVICE WAS USED AS PART OF THE SURGICAL PROCEDURE. SURGICAL PROCEDURE AND DEVICE IMPLANT ON (B)(6) 2016. SYMPTOMS OF INFECTION STARTED ON (B)(6) 2016. DEVICE EXPLANT ON (B)(6) 2016 DUE TO INFECTION WITH ASSOCIATED PAIN. DURING EXPLANT IT WAS NOTED THAT THE "DEHISCENT WOUND DEEPENED AND [DEVICE] VISUALIZED." DEVICE WAS FOUND IN THE CORRECT POSITION AT TIME OF EXPLANT. AFTER REMOVAL, PATIENT HAD A CLEAN WOUND THAT WAS HEALING ON (B)(6) 2016. PATIENT IS BEING MANAGED BY THEIR SURGEON AS THEY ARE STRUGGLING WITH BOWEL FUNCTION (PATIENT FELT SYMPTOMS ARE WORSE THAN PRE-IMPLANT).

    Description of Event or Problem · 1

    FOLLOWING A SURGICAL PROCEDURE FOR REINFORCEMENT OF THE ANAL SPHINCTER DUE TO FECAL INCONTINENCE, A PATIENT EXPERIENCED AN INFECTION AND RELATED PAIN LEADING TO FENIX DEVICE EXPLANT. THE FENIX DEVICE WAS USED AS PART OF THE SURGICAL PROCEDURE. SURGICAL PROCEDURE AND DEVICE IMPLANT ON (B)(6) 2016. SYMPTOMS OF INFECTION STARTED ON (B)(6) 2016. DEVICE EXPLANT ON (B)(6) 2016 DUE TO INFECTION WITH ASSOCIATED PAIN. DURING EXPLANT IT WAS NOTED THAT THE "DEHISCENT WOUND DEEPENED AND [DEVICE] VISUALIZED." DEVICE WAS FOUND IN THE CORRECT POSITION AT TIME OF EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768005 FENIX CONTINENCE RESTRORATION SYSTEM IMPLANTED FECAL INCONTINENCE DEVICE PMH TORAX MEDICAL, INC. FS16 8656

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| O