BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FENIX CONTINENCE RESTRORATION SYSTEM

    MDR report key: 5661397 · Received May 17, 2016

    Report

    Report Number
    3008766073-2016-00037
    Event Type
    Injury
    Date Received
    May 17, 2016
    Date of Event
    April 18, 2016
    Report Date
    September 28, 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

    PATIENT REPORTED RETURN OF INCONTINENCE (POTENTIALLY WORSE THAN PRE-IMPLANT) AND OBSTRUCTIVE DEFECATION SYMPTOMS AFTER DEVICE EXPLANT. UPDATED/CORRECTED PRODUCT CODE FROM MIP TO PMH BASED ON AVAILABILITY OF PMH CODE.

    Additional Manufacturer Narrative · 1

    PATIENT REPORTED RETURN OF INCONTINENCE (POTENTIALLY WORSE THAN PRE-IMPLANT) AND OBSTRUCTIVE DEFECATION SYMPTOMS AFTER DEVICE EXPLANT. PATIENT'S OBSTRUCTIVE DEFECATION RESOLVED PER PROCTOGRAM TEST PERFORMED ON (B)(6) 2016. UPDATED/CORRECTED PRODUCT CODE FROM MIP TO PMH BASED ON AVAILABILITY OF PMH CODE. REVISED MANUFACTURE DATE FROM 08/12/2013 TO 08/15/2013. REVISED EXPIRATION DATE FROM 08/12/2017 TO 08/15/2017. REVISED PATIENT AGE AT TIME OF EVENT BASED ON AVAILABILITY OF DATE OF BIRTH.

    Description of Event or Problem · 1

    FOLLOWING A SURGICAL PROCEDURE FOR REINFORCEMENT OF THE ANAL SPHINCTER DUE TO FECAL INCONTINENCE, A PATIENT EXPERIENCED ANAL PAIN LEADING TO FENIX DEVICE EXPLANT. THE FENIX DEVICE WAS USED AS PART OF THE SURGICAL PROCEDURE. UNEVENTFUL SURGICAL PROCEDURE AND DEVICE IMPLANT ON (B)(6) 2016. UNEVENTFUL DEVICE EXPLANT IN (B)(6) 2016 DUE TO ANAL PAIN. PATIENT REPORTED DIFFICULTY OPENING BOWELS DESPITE LAXATIVES. DEVICE EXPLANTED THROUGH THE PERINEAL INCISION. IT WAS REPORTED NO INFECTION EXISTED AND DEVICE WAS FOUND IN CORRECT POSITION/GEOMETRY. ONE WEEK POST DEVICE EXPLANT PATIENT REPORTED "SORENESS", BUT THE PAIN DISAPPEARED WHEN THE DEVICE WAS REMOVED.

    Description of Event or Problem · 1

    FOLLOWING A SURGICAL PROCEDURE FOR REINFORCEMENT OF THE ANAL SPHINCTER DUE TO FECAL INCONTINENCE, A PATIENT EXPERIENCED ANAL PAIN LEADING TO FENIX DEVICE EXPLANT. THE FENIX DEVICE WAS USED AS PART OF THE SURGICAL PROCEDURE. UNEVENTFUL SURGICAL PROCEDURE AND DEVICE IMPLANT ON (B)(6) 2016. UNEVENTFUL DEVICE EXPLANT IN (B)(6) 2016 DUE TO ANAL PAIN. PATIENT REPORTED DIFFICULTY OPENING BOWELS DESPITE LAXATIVES. DEVICE EXPLANTED THROUGH THE PERINEAL INCISION. IT WAS REPORTED NO INFECTION EXISTED AND DEVICE WAS FOUND IN CORRECT POSITION/GEOMETRY. ONE WEEK POST DEVICE EXPLANT PATIENT REPORTED "SORENESS", BUT THE PAIN DISAPPEARED WHEN THE DEVICE WAS REMOVED.

    Description of Event or Problem · 1

    FOLLOWING A SURGICAL PROCEDURE FOR REINFORCEMENT OF THE ANAL SPHINCTER DUE TO FECAL INCONTINENCE, A PATIENT EXPERIENCED ANAL PAIN LEADING TO FENIX DEVICE EXPLANT. THE FENIX DEVICE WAS USED AS PART OF THE SURGICAL PROCEDURE. UNEVENTFUL SURGICAL PROCEDURE AND DEVICE IMPLANT ON (B)(6) 2016. UNEVENTFUL DEVICE EXPLANT IN (B)(6) 2016 DUE TO ANAL PAIN. PATIENT REPORTED DIFFICULTY OPENING BOWELS DESPITE LAXATIVES. DEVICE EXPLANTED THROUGH THE PERINEAL INCISION. THE PATIENT'S DIFFICULTY OPENING BOWELS HAS RESOLVED AS OF (B)(6) 2016. IT WAS REPORTED NO INFECTION EXISTED AND DEVICE WAS FOUND IN CORRECT POSITION/GEOMETRY. ONE WEEK POST DEVICE EXPLANT PATIENT REPORTED "SORENESS," BUT THE PAIN DISAPPEARED WHEN THE DEVICE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314329 FENIX CONTINENCE RESTRORATION SYSTEM IMPLANTED FECAL INCONTINENCE DEVICE PMH TORAX MEDICAL, INC. FS14 5101

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| S