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 Pain (1994)

Event Date 12/01/2015

Event Type  Injury  

Event Description

Following a surgical procedure for reinforcement of the anal sphnicter due to fecal incontinence, a patient experienced anal 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) 2015.Uneventful device explant in (b)(6) 2015 due to multiple months of anal pain.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: kevin klitz ; 4188 lexington avenue north; shoreview, MN 55126 ; 6513618900
• MDR Report Key: 5482711
• MDR Text Key: 39733488
• Report Number: 3008766073-2016-00013
• Device Sequence Number: 0
• Product Code: PMH
• 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: 02/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/16/2016
• Device Model Number: FS19
• Device Lot Number: 3742
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2012
• 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; Disability
• Patient Age: 44 YR