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

Model Number FS16

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

Patient Problems Inflammation (1932); Pain (1994)

Event Date 02/08/2017

Event Type  Injury  

Event Description

Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient experienced anal pain and perineal inflammation 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) 2013.- patient began having worsening symptoms on (b)(6) 2016.- uneventful device explant on (b)(6) 2017 due to anal pain and perineal inflammation; the device was removed through the original incision.- the device was found in the correct position/geometry at the time of removal.- patient is "doing well" as of (b)(6) 2017.

Event Description

Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient experienced anal pain and perineal inflammation 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) 2013.Patient experienced "severe anal pain with inflammation" beginning in (b)(6) 2016.Symptoms were clinically managed with antibiotics (ciflox, then flagyl).Patient began having worsening symptoms on (b)(6) 2016.Device explant on (b)(6) 2017 due to anal pain and perineal inflammation; the device was removed through the original incision.It was noted during explant that there were no signs of infection and that "significant" bleeding made the removal "difficult." the device was found in the correct position/geometry at the time of removal.Patient was hospitalized (b)(6) 2017 for the device removal.Patient is "doing well" as of (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: 6970070
• MDR Text Key: 90036587
• Report Number: 3008766073-2017-00121
• 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,Followup
• Report Date: 11/08/2017

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: 11/18/2015
• Device Model Number: FS16
• Device Lot Number: 3176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/24/2017
• Initial Date FDA Received: 10/23/2017
• Supplement Dates Manufacturer Received: 11/08/2017
• Supplement Dates FDA Received: 11/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2011
• 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: 79 YR
• Patient Weight: 100