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

Model Number FXS15

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

Patient Problem Constipation (3274)

Event Date 09/20/2017

Event Type  Injury  

Event Description

Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient experienced obstructive symptoms and constipation 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) 2017.Patient discussed symptoms with physician on (b)(6) 2017 and did not wish to continue to use laxatives to facilitate bowel movements.Uneventful device explant on (b)(6) 2017 due to obstructive symptoms and constipation; the device was removed through the original incision.The device was found in the correct position/geometry at the time of 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: 6965160
• MDR Text Key: 89845646
• Report Number: 3008766073-2017-00120
• Device Sequence Number: 1
• Product Code: PMH
• UDI-Device Identifier: 00855106005486
• UDI-Public: 00855106005486
• 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: 09/21/2017

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: 03/17/2020
• Device Model Number: FXS15
• Device Lot Number: 10521
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/21/2017
• Initial Date FDA Received: 10/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2016
• 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; Disability
• Patient Age: 47 YR