FENIX CONTINENCE RESTORATION SYSTEM FS19 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 2018-02-23 for FENIX CONTINENCE RESTORATION SYSTEM FS19 NA manufactured by Torax Medical, Inc..

Event Text Entries

[100844797] 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) 2016. A flexible sigmoidoscopy on (b)(6) 2017 showed 4 beads exposed at the posterior anal canal. The patient's exposure symptoms began 2 months prior to the erosion discovery. Uneventful device explant (b)(6) 2017 due to 4 fenix device beads found eroded through the posterior anal canal. The fenix device was removed through the original incision. The device was intact at the time of explant. It was observed that the device "was well integrated into the soft tissue" at the time of explant. The patient was reported as "doing okay" after removal.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3008766073-2018-00026
MDR Report Key7293805
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-02-23
Date of Report2018-01-28
Date of Event2017-06-09
Date Mfgr Received2018-01-28
Device Manufacturer Date2015-02-04
Date Added to Maude2018-02-23
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 Received2018-02-23
Model NumberFS19
Catalog NumberNA
Lot Number7541
Device Expiration Date2019-02-04
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 2018-02-23

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