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

Model Number FS14

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

Patient Problems Erosion (1750); Unspecified Infection (1930); Pain (1994)

Event Date 03/03/2016

Event Type  Injury  

Event Description

Following a surgical procedure for reinforcement of the anal sphnicter due to fecal incontinence, a patient experienced infection and rectal pain leading to erythema near the implant site and erosion of the fenix device leading to fenix device explant.The fenix device was used as part of the surgical procedure.Surgical procedure and device implant on (b)(6) 2016 by dr (b)(6).Patient went to the hospital due to peri-anal pain and erythema around the surgical implant site on (b)(6) 2016.Patient was evaluated for crp levels and found to have an elevated level indicating an infection.The patient was administered analgesia and antibiotics.Patient returned to the hospital for severe peri-anal pain on (b)(6) 2016.The patient was examined and diagnosed with an erosion of the device through the anterior rectum.The patient was subsequently admitted and the device removed on (b)(6) 2016.The patient recovered in the hospital and was discharged on (b)(6) 2016 after completing a course of oral antibiotics.

Event Description

Following a surgical procedure for reinforcement of the anal sphnicter due to fecal incontinence, a patient experienced infection and rectal pain leading to erythema near the implant site and erosion of the fenix device leading to fenix device explant.The fenix device was used as part of the surgical procedure.Surgical procedure and device implant on (b)(6) 2016 by dr.(b)(6).Patient went to the hospital due to peri-anal pain and erythema around the surgical implant site on (b)(6) 2016.Patient was evaluated for crp levels and found to have an elevated level indicating an infection.The patient was administered analgesia and antibiotics.Patient returned to the hospital for severe peri-anal pain on (b)(6) 2016.The patient was examined and diagnosed with an erosion of the device through the anterior rectum.The patient was subsequently admitted and the device removed on (b)(6) 2016.The patient recovered in the hospital and was discharged on (b)(6) 2016 after completing a course of oral antibiotics.

• 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: 5533170
• MDR Text Key: 41408267
• Report Number: 3008766073-2016-00024
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/03/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/12/2017
• Device Model Number: FS14
• Device Lot Number: 5101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2013
• 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: 64 YR