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

Model Number FS18

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

Patient Problem No Code Available (3191)

Event Date 11/07/2017

Event Type  Injury  

Event Description

Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient required an mri for back pain 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) 2014.-device explant on (b)(6) 2017 due to the need for an mri.The device was found in the correct position/geometry.-patient was successfully treated for post-operative infection with flagyl and some "superficial dehiscence" was observed at the perineal wound 3 weeks after device 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: 7343050
• MDR Text Key: 102571474
• Report Number: 3008766073-2018-00039
• Device Sequence Number: 1
• Product Code: PMH
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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: 02/13/2018

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: 07/11/2016
• Device Model Number: FS18
• Device Lot Number: 3740
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/13/2018
• Initial Date FDA Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2012
• 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: 50 YR