FDA.reportPublic FDA data

MAUDE MDR 6064941

MDR report key
6064941
Report number
3008766073-2016-00076
Event key
0
Event type
3
Date of event
2016-08-18
Date received
2016-10-28
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 RESTRORATION SYSTEMIMPLANTED FECAL INCONTINENCE DEVICETORAX MEDICAL, INC.PMHFXS19NA10061R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-10-2801. H; 2. O

Event Narratives#

D

Patient 1

FOLLOWING A SURGICAL PROCEDURE FOR REINFORCEMENT OF THE ANAL SPHINCTER DUE TO FECAL INCONTINENCE, A PATIENT EXPERIENCED A PAIN AND WOUND DEHISCENCE 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. PATIENT WAS MONITORED FOR PAIN AND PROPHYLACTICALLY TREATED WITH ANTIBIOTICS. PATIENT RECEIVED IV ANTIBIOTICS 13 DAYS AFTER IMPLANT AND PATIENT REPORTED SYMPTOMS OF CONSTIPATION AND PAIN. DEVICE EXPLANT THROUGH SURGICAL SITE ON (B)(6) 2016 DUE TO PAIN AND WOULD DEHISCENCE. PHYSICIAN REPORTED THAT DURING DEVICE EXPLANT THE DEVICE GOT HUNG UP ON A LIGAMENT. A CLAMP WAS APPLIED TO EACH END OF THE CUT DEVICE AND A "GREAT DEAL OF FORCE" WAS APPLIED; ENOUGH TO BREAK A DEVICE CONNECTING WIRE. DEVICE WAS FOUND IN THE CORRECT POSITION AT TIME OF EXPLANT. PATIENT IS RECOVERING WELL.

N

Patient 1

(B)(4).

D

Patient 1

FOLLOWING A SURGICAL PROCEDURE FOR REINFORCEMENT OF THE ANAL SPHINCTER DUE TO FECAL INCONTINENCE, A PATIENT EXPERIENCED A PAIN AND WOUND DEHISCENCE 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. -PATIENT WAS MONITORED FOR PAIN AND PROPHYLACTICALLY TREATED WITH ANTIBIOTICS. -PATIENT RECEIVED IV ANTIBIOTICS 13 DAYS AFTER IMPLANT AND PATIENT REPORTED SYMPTOMS OF CONSTIPATION AND PAIN. -DEVICE EXPLANT THROUGH SURGICAL SITE ON (B)(6) 2016 DUE TO PAIN AND WOUND DEHISCENCE. -PHYSICIAN REPORTED THAT DURING DEVICE EXPLANT THE DEVICE GOT HUNG UP ON A LIGAMENT. A CLAMP WAS APPLIED TO EACH END OF THE CUT DEVICE AND A "GREAT DEAL OF FORCE" WAS APPLIED; ENOUGH TO BREAK A DEVICE CONNECTING WIRE. -DEVICE WAS FOUND IN THE CORRECT POSITION AT TIME OF EXPLANT. -PATIENT IS RECOVERING WELL.