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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORAX MEDICAL, INC. FENIX CONTINENCE RESTORATION SYSTEM; IMPLANTED FECAL INCONTINENCE DEVICE
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TORAX MEDICAL, INC. FENIX CONTINENCE RESTORATION SYSTEM; IMPLANTED FECAL INCONTINENCE DEVICE Back to Search Results
Model Number FS15
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 03/16/2017
Event Type  Injury  
Event Description
Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient experienced anal pain leading to fenix device explant.The fenix device was used as part of the surgical procedure.Uneventful device explant in (b)(6) 2017 due to anal pain.Multiple requests have been made for more information.
 
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Brand Name
FENIX CONTINENCE RESTORATION SYSTEM
Type of Device
IMPLANTED FECAL INCONTINENCE DEVICE
Manufacturer (Section D)
TORAX MEDICAL, INC.
4188 lexington avenue n
shoreview MN 55126
Manufacturer (Section G)
TORAX MEDICAL, INC.
4188 lexington avenue north
shoreview MN 55126
Manufacturer Contact
jessica ahlborn
4188 lexington avenue north
shoreview, MN 55126
6513618900
MDR Report Key6493405
MDR Text Key72836851
Report Number3008766073-2017-00045
Device Sequence Number1
Product Code PMH
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
H130006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 03/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Model NumberFS15
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/30/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/16/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Disability;
Patient Age64 YR
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