FENIX CONTINENCE RESTORATION SYSTEM FS14 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 2017-07-27 for FENIX CONTINENCE RESTORATION SYSTEM FS14 NA manufactured by Torax Medical, Inc..

Event Text Entries

[81234744] Following a surgical procedure for reinforcement of the anal sphnicter due to fecal incontinence, a patient was found to have fenix beads eroded ventrally 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) 2016. The patient has had very hard stool and manipulated it with her fingers to get it out several times. Uneventful device explant (b)(6) 2017 due to 5 fenix device beads eroded ventrally through the anal canal. The fenix device was removed transanally. The device was intact at the time of explant.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3008766073-2017-00081
MDR Report Key6748460
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2017-07-27
Date of Report2018-02-13
Date of Event2017-06-22
Date Mfgr Received2018-02-13
Device Manufacturer Date2015-07-27
Date Added to Maude2017-07-27
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 Received2017-07-27
Returned To Mfg2017-07-25
Model NumberFS14
Catalog NumberNA
Lot Number8649
Device Expiration Date2019-07-27
OperatorPHYSICIAN
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
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 2017-07-27

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