FENIX CONTINENCE RESTORATION SYSTEM FS20 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 2018-03-15 for FENIX CONTINENCE RESTORATION SYSTEM FS20 NA manufactured by Torax Medical, Inc..

Event Text Entries

[102451180] Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient experienced an erosion of the fenix device into the anal canal leading to device explant. The fenix device was used as part of the surgical procedure. -uneventful surgical procedure and device implant on (b)(6) 2015. The patient was given pre-op prophylactic antibiotics. A pelvic x-ray was taken during the implant procedure showing the device in an acceptable position. -patient was discharged from the hospital on (b)(6) 2015 with no adverse events from the procedure noted. -the patient presented to the clinic on (b)(6) 2016 with acute pain in the anus and reported having noticed blood. The device was found "inserted into the rectum from 11 o'clock to 10 o'clock and could be felt below the mucosa. " -patient admitted to the hospital for device explant on (b)(6) 2016. -uneventful device explant on (b)(6) 2016 due to fenix device erosion. The fenix device was intact. -patient was reported as doing well after explant.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3008766073-2018-00034
MDR Report Key7340861
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-03-15
Date of Report2018-02-13
Date of Event2016-12-19
Date Mfgr Received2018-02-13
Device Manufacturer Date2013-08-08
Date Added to Maude2018-03-15
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 Received2018-03-15
Returned To Mfg2018-03-06
Model NumberFS20
Catalog NumberNA
Lot Number5078
Device Expiration Date2017-08-08
OperatorPHYSICIAN
Device AvailabilityR
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 2018-03-15

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