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

Model Number FXS20

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

Patient Problems Wound Dehiscence (1154); Post Operative Wound Infection (2446)

Event Type  Injury  

Event Description

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.

• 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: 6116684
• MDR Text Key: 60546665
• Report Number: 3008766073-2016-00092
• Device Sequence Number: 1
• Product Code: PMH
• UDI-Device Identifier: 00855106005530
• UDI-Public: 00855106005530
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/25/2016

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: 03/16/2020
• Device Model Number: FXS20
• Device Lot Number: 10526
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2016
• Initial Date FDA Received: 11/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2016
• 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: 46 YR