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

Model Number	FXS15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Constipation (3274)
Date of Event	09/20/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient experienced obstructive symptoms and constipation 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.Patient discussed symptoms with physician on (b)(6) 2017 and did not wish to continue to use laxatives to facilitate bowel movements.Uneventful device explant on (b)(6) 2017 due to obstructive symptoms and constipation; the device was removed through the original incision.The device was found in the correct position/geometry at the time of removal.

• Brand Name: FENIX CONTINENCE RESTORATION SYSTEM
• Common Device Name: IMPLANTED FECAL INCONTINENCE DEVICE
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue n; shoreview MN 55126
• MDR Report Key: 6965160
• Report Number: 3008766073-2017-00120
• Device Sequence Number: 565899
• Product Code: PMH
• UDI-Device Identifier: 00855106005486
• UDI-Public: 00855106005486
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: H130006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2017

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
• Operator of Device: Physician
• Device Expiration Date: 03/17/2020
• Device Model Number: FXS15
• Device Lot Number: 10521
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 10/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Disability
• Patient Age: 47 YR