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

Model Number FS16

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

Patient Problem Post Operative Wound Infection (2446)

Event Date 10/26/2016

Event Type  Injury  

Event Description

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.

Manufacturer Narrative

Addition to include patient status after removal (infection healed and patient experiencing fi symptoms worse than pre-implant).

Event Description

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).

• Brand Name: FENIX CONTINENCE RESTRORATION 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: daniel hoseck ; 4188 lexington avenue north; shoreview, MN 55126 ; 6513618900
• MDR Report Key: 6116685
• MDR Text Key: 60547870
• Report Number: 3008766073-2016-00093
• 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,Followup
• Report Date: 11/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 07/27/2019
• Device Model Number: FS16
• Device Lot Number: 8656
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2016
• Initial Date FDA Received: 11/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2015
• 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; Other
• Patient Age: 45 YR