FDA.reportPublic FDA data

MAUDE MDR 4146933

MDR report key
4146933
Report number
9615058-2014-00006
Event key
0
Event type
3
Date of event
2014-09-17
Date received
2014-09-24
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
ORI LUBIN, MANAGER
Address
5 NAHUM ST. PO BOX 2039 TIRAT CARMEL 31290 IS
Phone
544-544-5448
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MRGFUS EXABLATEHIFUINSIGHTEC, LTD.NRZ2000Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-09-2401. D

Event Narratives#

D

Patient 1

A (B)(6) YEAR OLD WOMAN WITH ADENOMYOSIS AND MENOMETRORRHAGIA WAS "COMMERCIALLY" TREATED ON (B)(6) WITH NO REMARKABLE EVENTS. IN HR PAS THE PATIENT UNDERWENT MYOMECTOMY BY LAPAROTOMY AND SEVERAL IVF ATTEMPTS. THREE DAYS POST-TREATMENT ((B)(6) 2014) THE PATIENT COMPLAINT OF ABDOMINAL PAIN AND WAS REFERRED TO THE EMERGENCY ROOM. SHE ARRIVED TO THE ER ON (B)(6) 2014. FOLLOWING DETERIORATION OF HER CONDITION, SHE WAS TAKEN TO EMERGENCY FOR A LAPAROTOMY. IT WAS REPORTED INDIRECTLY TO INSIGHTEC THAT AT LAPAROTOMY FECES WAS FOUND IN THE ABDOMINAL CAVITY BUT NO APPARENT PERFORATION OF PERFORATION SITE WAS DETECTED. THE PATIENT DIES ON (B)(6) 2014. ON (B)(6) PM WAS PERFORMED. AT THIS TIME, THE PM RESULTS ARE NOT AVAILABLE, PER HOSPITAL MANAGEMENT DECISION. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME AS WELL.

N

Patient 1

DEVICE HAS BEEN DIAGNOSED AND FOUND WITH NO MALFUNCTIONS. SITE DID NOT ALLOW TREATMENT REVIEW YET.