FENIX CONTINENCE RESTORATION SYSTEM FS18 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-10-24 for FENIX CONTINENCE RESTORATION SYSTEM FS18 NA manufactured by Torax Medical, Inc..

Event Text Entries

[90105200] Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient experienced an infection and anal pain 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) 2009. - patient began having infection and pain symptoms on (b)(6) 2017. - x-ray taken at 5-year study follow-up shows device in an annular state with no gaps between any beads. -uneventful device explant on (b)(6) 2017 due to infection and anal pain; the device was removed through the original incision. - the device was found in the correct position/geometry at the time of removal. - it was reported that the "the device was already opened when the procedure was made: the surgical thread was broken". -an anal abscess was observed, positioned at "3 o'clock". -patient is "doing well" as of (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3008766073-2017-00123
MDR Report Key6973303
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2017-10-24
Date of Report2017-09-28
Date of Event2017-04-29
Date Mfgr Received2017-09-28
Device Manufacturer Date2009-08-03
Date Added to Maude2017-10-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. TRESSA LAUER
Manufacturer Street4188 LEXINGTON AVENUE NORTH
Manufacturer CitySHOREVIEW MN 55126
Manufacturer CountryUS
Manufacturer Postal55126
Manufacturer Phone6513618900
Manufacturer G1TORAX MEDICAL, INC.
Manufacturer Street4188 LEXINGTON AVENUE NORTH
Manufacturer CitySHOREVIEW MN 55126
Manufacturer CountryUS
Manufacturer Postal Code55126
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFENIX CONTINENCE RESTORATION SYSTEM
Generic NameIMPLANTED FECAL INCONTINENCE DEVICE
Product CodePMH
Date Received2017-10-24
Model NumberFS18
Catalog NumberNA
Lot Number1944
Device Expiration Date2011-08-03
OperatorPHYSICIAN
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTORAX MEDICAL, INC.
Manufacturer Address4188 LEXINGTON AVENUE N SHOREVIEW MN 55126 US 55126


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Deathisabilit 2017-10-24

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