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

Model Number FXS16

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

Patient Problem Erosion (1750)

Event Date 07/20/2017

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 fenix beads 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)2017; 3-4 vessels were stitched during the implant procedure to decrease bleeding.-the patient presented with discharge and tenderness; during a digital rectal exam the device was found to have eroded into the anterior rectum on (b)(6)2017.Symptoms began (b)(6)2017.-uneventful device explant (b)(6)2017 due to 2 fenix device beads found eroded through the anal canal; an infection was present at the exposure site.The fenix device was removed transanally.The device was intact at the time of explant.

Manufacturer Narrative

(b)(4).

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 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) 2017; 3-4 vessels were stitched during the implant procedure to decrease bleeding.The patient presented with discharge and tenderness; during a digital rectal exam the device was found to have eroded into the anterior rectum on (b)(6) 2017.Symptoms began (b)(6) 2017.Uneventful device explant (b)(6) 2017 due to 2 fenix device beads found eroded through the anal canal; an infection was present at the exposure site.The fenix device was removed transanally.The device was intact at the time of explant.The patient was reported as doing well after removal.

• 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: jessica ahlborn ; 4188 lexington avenue north; shoreview, MN 55126 ; 6513618900
• MDR Report Key: 6802365
• MDR Text Key: 82977162
• Report Number: 3008766073-2017-00095
• Device Sequence Number: 1
• Product Code: PMH
• UDI-Device Identifier: 00855106005493
• UDI-Public: 00855106005493
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/16/2020
• Device Model Number: FXS16
• Device Lot Number: 10522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2016
• 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: 76 YR