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

Model Number FS17

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

Patient Problem Pain (1994)

Event Date 01/05/2016

Event Type  Injury  

Event Description

Following a surgical procedure for reinforcement of the anal sphnicter due to fecal incontinence, a patient experienced rectal pain and visualization of the fenix device in the rectum 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 (b)(6) 2016 due to visualization (erosion) of two beads of the fenix in the rectum.The fenix device was intact.Device explanted through the rectum without issue.The implanting physician believes the fenix implant was placed in the area of a previous surgical staple line/scar.The patient was examined after device explant on (b)(6) 2016 and it was determined that the wound was well healed and the patient condition fine.

• 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: 5417863
• MDR Text Key: 37714660
• Report Number: 3008766073-2016-00009
• 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: 01/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/07/2017
• Device Model Number: FS17
• Device Lot Number: 5076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2013
• 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; Disability
• Patient Age: 78 YR