FENIX CONTINENCE RESTRORATION 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 2016-07-26 for FENIX CONTINENCE RESTRORATION SYSTEM FS19 NA manufactured by Torax Medical, Inc..

Event Text Entries

[50462555] Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient experienced an infection and related pain 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. Prior to device implant during blunt dissection the surgeon perforated the skin posterior to the anus. The perforation was repaired with monocryl suture. Once repaired the surgeon created a more anterior dissection path for device implant. Patient reported onset of infection symptoms as (b)(6) 2016. The patient was administered antibiotics and analgesia on (b)(6) 2016. Device explant (b)(6) 2016 due to reported infection with associated pain. Device explanted at transperineal incision site. Device was found in the correct position at time of explant. Patient is reportedly pain free and the wound has healed after explant; both are indications that the infection has been resolved.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3008766073-2016-00051
MDR Report Key5822866
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2016-07-26
Date of Report2016-06-30
Date of Event2016-06-21
Date Mfgr Received2016-06-30
Device Manufacturer Date2015-07-29
Date Added to Maude2016-07-26
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 ContactMR. DANIEL HOSECK
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 RESTRORATION SYSTEM
Generic NameIMPLANTED FECAL INCONTINENCE DEVICE
Product CodePMH
Date Received2016-07-26
Model NumberFS19
Catalog NumberNA
Lot Number8659
Device Expiration Date2019-07-29
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 2016-07-26

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