FDA.reportPublic FDA data

MAUDE MDR 8575024

MDR report key
8575024
Report number
2951226-2017-00001
Event key
0
Event type
3
Date of event
2017-02-17
Date received
2019-05-02
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
MRS REBECCA WOOD
Address
4000 PENDLETON WAY INDIANAPOLIS IN 46226 US
Phone
317-317-3177
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SONABLATEHIGH INTENSITY FOCUSED ULTRASOUND DEVICEFOCUS SURGERY, INCPLPSONABLATEY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-05-0201. O

Event Narratives#

N

Patient 1

.

D

Patient 1

THE PATIENT HAD A WHOLE GLAND ABLATION IN FEBRUARY POST OP HE WAS VERY CONSTIPATED FOR ONE WEEK TREATED WITH ORAL MEDICATION HAD DIARRHEA FOR FEW WEEKS NO RECTAL SUPPOSITORY OR ENEMA WAS USED HE COMPLAINED THE FOURTH WEEK POST OP OF REGULAR BOWL MOVEMENT BUT A TEASPOON OF CLEAR LIQUID DRAINAGE AFTER THE BOWL MOVEMENT CYSTOGRAM SHOWED SMALL RECTAL FISTULA. PATIENT WAS REFERRED TO USC FOR REPAIR AS CONSERVATIVE S/P DRAINAGE DID NOT CLOSE THE FISTULA" AND AGAIN AFTER ANOTHER FOLLOW UP THE FOLLOWING RESPONSE WAS RECEIVED FROM THE PHYSICIAN: "PROCEDURE WAS DONE ON 17 FEBRUARY I BELIEVE HIS CONSTIPATION AND STRAINING TO STOOL AND VOID COULD HAVE CONTRIBUTED TO THE FISTULA PLEASE REVIEW CASE AND LET ME KNOW.