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 Problem Erosion (1750)

Event Date 06/09/2017

Event Type  Injury  

Event Description

Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient was found to have fenix beads eroded through the anal canal 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.A flexible sigmoidoscopy on (b)(6) 2017 showed 4 beads exposed at the posterior anal canal.The patient's exposure symptoms began 2 months prior to the erosion discovery.Uneventful device explant (b)(6) 2017 due to 4 fenix device beads found eroded through the posterior anal canal.The fenix device was removed through the original incision.The device was intact at the time of explant.It was observed that the device "was well integrated into the soft tissue" at the time of explant.The patient was reported as "doing okay" 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: 7293805
• MDR Text Key: 100844797
• Report Number: 3008766073-2018-00026
• 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: 01/28/2018

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: 02/04/2019
• Device Model Number: FS19
• Device Lot Number: 7541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/28/2018
• Initial Date FDA Received: 02/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2015
• 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: 64 YR