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

Model Number FS14

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

Patient Problem Erosion (1750)

Event Date 06/22/2017

Event Type  Injury  

Event Description

Following a surgical procedure for reinforcement of the anal sphnicter due to fecal incontinence, a patient was found to have fenix beads eroded ventrally 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) 2016.The patient has had very hard stool and manipulated it with her fingers to get it out several times.Uneventful device explant (b)(6) 2017 due to 5 fenix device beads eroded ventrally through the anal canal.The fenix device was removed transanally.The device was intact at the time of explant.

Event Description

Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient was found to have fenix beads eroded ventrally 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) 2016.The patient has had very hard stool and manipulated it with her fingers to get it out several times.Uneventful device explant (b)(6) 2017 due to 5 fenix device beads eroded ventrally through the anal canal.The fenix device was removed transanally.The device was intact at the time of explant.

Event Description

Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient was found to have fenix beads eroded ventrally 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) 2016.The patient was given pre-op prophylactic.An x-ray was performed during the implant procedure showing the device in the correct location and in an annular state.Patient was discharged from hospital on (b)(6) 2016 with no adverse events noted after surgery.The patient has had very hard stool and manipulated it with her fingers to get it out several times.Patient was admitted to the hospital on (b)(6) 2017.Uneventful device explant (b)(6) 2017 due to 5 fenix device beads eroded ventrally through the anal canal.The fenix device was removed transanally.The device was intact at the time of explant.Patient was discharged from the hospital on (b)(6) 2017.

• 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: 6748460
• MDR Text Key: 81234744
• Report Number: 3008766073-2017-00081
• Device Sequence Number: 1
• Product Code: PMH
• Combination Product (y/n): N
• 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,Followup,Followup
• 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: 07/27/2019
• Device Model Number: FS14
• Device Lot Number: 8649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/27/2017
• Initial Date FDA Received: 07/27/2017
• Supplement Dates Manufacturer Received: 08/08/2017; 02/13/2018
• Supplement Dates FDA Received: 09/06/2017; 03/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2015
• 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: 84 YR
• Patient Weight: 60