FDA.reportPublic FDA data

MAUDE MDR 6657162

MDR report key
6657162
Report number
3008766073-2017-00060
Event key
0
Event type
3
Date of event
2017-05-22
Date received
2017-06-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. JESSICA AHLBORN
Address
4188 LEXINGTON AVENUE NORTH SHOREVIEW MN 55126 US
Phone
651-651-6513
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1FENIX CONTINENCE RESTORATION SYSTEMIMPLANTED FECAL INCONTINENCE DEVICETORAX MEDICAL, INC.PMHFS17NA6116Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-06-2101. H; 2. S

Event Narratives#

D

Patient 1

FOLLOWING A SURGICAL PROCEDURE FOR REINFORCEMENT OF THE ANAL SPHINCTER DUE TO FECAL INCONTINENCE, A PATIENT EXPERIENCED ANAL PAIN AND LACK OF EFFECT 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) 2015. -PAIN STARTED IN (B)(6) 2017. -UNEVENTFUL DEVICE EXPLANT ON (B)(6) 2017 DUE TO ANAL PAIN AND LACK OF EFFECT. -THE DEVICE WAS NOTED TO HAVE DISLOCATION IN THE CAUDAL DIRECTION.