FDA.reportPublic FDA data

MAUDE MDR 2346754

MDR report key
2346754
Report number
2346754
Event key
0
Event type
3
Date of event
2011-11-04
Date received
2011-11-18
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GYNECARE THERMACHOICE IIIUTERINE BALLOONETHICONMKN*TC003DJMG05 R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-11-180

Event Narratives#

D

Patient 1

THE PHYSICIAN WAS PREPARING TO USE THE DEVICE AND TESTED IT ON THE BACK TABLE. THE UTERINE BALLOON INFLATED, BUT READINGS INDICATED THAT THE BALLOON WAS NOT WORKING PROPERLY WHEN TESTING IT PRIOR TO USE. NO OBVIOUS VISUAL DEFECTS NOTED. MANUFACTURER REP WAS IN THE OR SUITE AT THE TIME AND WAS AWARE. MD DECIDED NOT TO USE THE DEVICE. OBTAINED A NEW DEVICE AND HAD NO DIFFICULTIES. NO PATIENT HARM. THE SCRUB AND CIRCULATOR DO NOT RECALL WHAT THE SPECIFIC READINGS WERE. THE DEVICE AND PACKAGING WERE SAVED AND SENT TO THE MANUFACTURER FOR INSPECTION/ANALYSIS. THE MANUFACTURER'S REP WAS PRESENT IN THE OR AT THE TIME OF THE EVENT AND WAS AWARE OF THE ABOVE.======================MANUFACTURER RESPONSE FOR UTERINE BALLOON, GYNECARE THERMACHOICE III (PER SITE REPORTER).======================THE MANUFACTURER'S REP WAS PRESENT IN THE OR AT THE TIME OF THE EVENT AND IS AWARE OF WHAT HAPPENED.