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

Model Number FS19

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

Patient Problem Incontinence (1928)

Event Date 04/21/2016

Event Type  Injury  

Event Description

Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient experienced fecal incontinence (lack of effect) leading to fenix device explant.The fenix device was used as part of the surgical procedure.Uneventful surgical procedure and device implant of a 19 bead device on (b)(6) 2015.Uneventful device explant on (b)(6) 2016 of 19 bead device due to lack of effect; a 16 bead device was implanted immediately after explant of the 19 bead device.Device explanted through the perineal incision.It was reported no infection existed and device was found in correct position/geometry.

• Brand Name: FENIX CONTINENCE RESTRORATION 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: daniel hoseck ; 4188 lexington avenue north; shoreview, MN 55126 ; 6513618900
• MDR Report Key: 5666790
• MDR Text Key: 45511386
• Report Number: 3008766073-2016-00038
• Device Sequence Number: 0
• Product Code: PMH
• 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: 04/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/25/2017
• Device Model Number: FS19
• Device Lot Number: 5567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2016
• Initial Date FDA Received: 05/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2013
• 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: 64 YR