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 2017-01-05 for FENIX CONTINENCE RESTORATION SYSTEM FS14 NA manufactured by Torax Medical, Inc..

Event Text Entries

[63976359] During a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient experienced a surgical complication of a posterior rectum perforation during implant dissection leading to fenix device explant. The fenix device was used as part of the surgical procedure. Surgical procedure and device implant on (b)(6) 2016. After closure of the wound during the surgical implant procedure, examination revealed visibility of partial fenix device through a perforation of the posterior rectum. Incision wound was reopened and device was explanted during the same surgery on (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3008766073-2017-00005
MDR Report Key6226619
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2017-01-05
Date of Report2016-12-08
Date of Event2016-12-07
Date Mfgr Received2016-12-08
Device Manufacturer Date2015-10-19
Date Added to Maude2017-01-05
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. JESSICA AHLBORN
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 Received2017-01-05
Model NumberFS14
Catalog NumberNA
Lot Number9338
Device Expiration Date2019-10-19
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. Other 2017-01-05

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