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

Model Number FS15

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

Patient Problem Erosion (1750)

Event Date 06/13/2017

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 anal canal 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 4 beads of the fenix device in the ventral lumen on (b)(6)2017.The fenix device was intact.The device was explanted transanally.-patient was reported as doing well after explant.

• 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: jessica ahlborn ; 4188 lexington avenue north; shoreview, MN 55126 ; 6513618900
• MDR Report Key: 6710757
• MDR Text Key: 79946334
• Report Number: 3008766073-2017-00076
• Device Sequence Number: 1
• Product Code: PMH
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 06/13/2017

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: FS15
• Device Lot Number: 8655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/13/2017
• Initial Date FDA Received: 07/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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; Disability
• Patient Age: 64 YR