MAUDE Adverse Event Report: TORAX MEDICAL, INC. FENIX CONTINENCE RESTORATION SYSTEM; IMPLANTED FECAL INCONTINENCE DEVICE

Model Number FS20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 11/21/2017

Event Type  Injury  

Event Description

Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient experienced an infection leading to fenix device explant.The fenix device was used as part of the surgical procedure.Surgical procedure and device implant on (b)(6) 2017.It was noted during implant procedure that it was a "difficult dissection due to previous anterior repair".Patient admitted to the hospital on (b)(6) 2017 with c-reactive protein levels of 88 mg/l and complaining of lower abdominal and back pain.Patient was examined under anesthetic and a manual evacuation of the rectum was performed.It was observed that the perineal wound was "clean" with "no induration or infection".The patient was given analgesia and laxatives and discharged (b)(6) 2017.Infection symptoms began (b)(6) 2017.Uneventful device explant on (b)(6) 2017 due to infection; the device was removed through a "chromic sinus at 11 o'clock".The device was found in the correct position/geometry at the time of removal.It was reported that the there was "no obvious pus" and that the wound was "left partially open".Three weeks after implant, the patient's "wound was clean and dry on examination, no evidence of infection".

• Brand Name: FENIX CONTINENCE RESTORATION SYSTEM
• Type of Device: IMPLANTED FECAL INCONTINENCE DEVICE
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue n; shoreview MN 55126
• Manufacturer (Section G): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN 55126
• Manufacturer Contact: tressa lauer ; 4188 lexington avenue north; shoreview, MN 55126 ; 6513618900
• MDR Report Key: 7128264
• MDR Text Key: 95238586
• Report Number: 3008766073-2017-00149
• Device Sequence Number: 1
• Product Code: PMH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: H130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 07/29/2019
• Device Model Number: FS20
• Device Lot Number: 8660
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 70 YR