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 Problems Erosion (1750); Pain (1994)

Event Date 04/25/2018

Event Type  Injury  

Event Description

Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient was found to have one fenix bead eroded through the anal canal 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.Clinical examination on (b)(6) 2018 revealed "right anterior skin ulceration which showed part of the magnetic sphincter 1 cm from the anus".The patient reported recent perianal pain with "no fever or suspicious oozing".Uneventful device explant (b)(6) 2018 due to 1 fenix device bead found eroded through the anterior right anal canal.The entire fenix device was removed through the original incision.The device was intact at the time of explant.It was observed that "there is a fibrous perianal tunnel, but the anus is still gaping.The rectal mucosa is visible, but does not go past the marginal plane, even under traction".It was also observed that there was no infection at the exposure site.The patient was reported as "doing as well [as] its possible" after as of (b)(6) 2018.

• 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: 7603232
• MDR Text Key: 111115122
• Report Number: 3008766073-2018-00098
• Device Sequence Number: 1
• Product Code: PMH
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• 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
• Date Manufacturer Received: 05/16/2018
• 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; Disability
• Patient Age: 83 YR