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

Model Number FS19

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

Patient Problems Erosion (1750); Unspecified Infection (1930)

Event Date 05/31/2017

Event Type  Injury  

Event Description

Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient experienced an erosion of the fenix device into the vagina leading to 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 on (b)(6) 2017 due to visualization (erosion) of 2 beads of the fenix device through the vaginal wall; the device eroded anteriorly.The fenix device was intact.The device was explanted through the original incision.-patient was reported as "healing slowly" after removal.

Event Description

Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient experienced an erosion of the fenix device into the vagina leading to device explant.The fenix device was used as part of the surgical procedure.Uneventful surgical procedure and device implant on (b)(6) 2016.Infection symptoms began in (b)(6) 2016.The wound was "visualized by prof.Steven brown, device visable and patient reporting discomfort and offensive smelling discharge" on (b)(6) 2016.Antibiotics were used to manage the infection.Patient recovered on (b)(6) 2017.Uneventful device explant on (b)(6) 2017 due to visualization (erosion) of 2 beads of the fenix device through the vaginal wall; the device eroded anteriorly.The fenix device was intact.The device was explanted through the original incision.Patient was reported as "healing slowly" after removal.

• 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: 6674184
• MDR Text Key: 78610713
• Report Number: 3008766073-2017-00068
• 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: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• 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: FS19
• Device Lot Number: 8659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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; Life Threatening; Disability
• Patient Age: 62 YR