FDA.reportPublic FDA data

MAUDE MDR 441709

MDR report key
441709
Report number
1722684-2003-00001
Event key
0
Event type
3
Date of event
2003-01-16
Date received
2003-02-07
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
WM. DEAN WALLANCE
Address
474 WEST 4170 SOUTH MURRY UT 84123 US
Phone
801-801-8012
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1KOALAINTRAUTERINE PRESSURE CATHETERCLINICAL INNOVATIONS, INC.HGSIPC-5000C**NRY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12003-02-0701. L; 2. R

Event Narratives#

D

Patient 1

CO'S SALES REP, REPORTED THE FOLLOWING: IN 2003 AT 12:55 PM, DR. DETEMINED THAT IT WAS NECESSARY TO UTILIZE A KOALA IPC 5000C. UPON INSERTION, CLINICIANS NOTICED A LARGE AMOUNT OF BLOOD DRAINING FROM THE CATHETER AND NOTED AN INCREASE IN VAGINAL BLEEDING. RAPID ONSET OF FETAL BRADYCARDIA NECESSITATED THE DELIVERY OF THE INFANT VIA EMERGENCY CEASAREAN DELIVERY. APGAR SCORES WERE 0 AT 1 MINUTE, 0 AT 5 MINUTES. 20 MINUTES OF RESUSCITATIVE EFFORTS AND AN EMERGENCY TRANSFUSION WERE REQUIRED TO STABILIZE THE PT. UPON DELIVERY OF THE PLACENTA, A PERFORATION AT THE JUNCTION OF THE UMBILICAL CORD AND THE PLACENTA WAS OBSERVED. THE PHYSICIAN'S IMPRESSION IS THAT THE IUPC PUNCTURED THE UMBILICAL CORD. THE BABY WAS STABILIZED AND SENT TO HOSP. BABY WAS DISCHARGED 1 WEEK LATER.