FDA.reportPublic FDA data

MAUDE MDR 4484048

MDR report key
4484048
Report number
MW5040570
Event key
0
Event type
3
Date of event
2015-01-23
Date received
2015-01-29
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1KOALA INTRAUTERINE PRESSURE MONITORING KITIUPCCLINICAL INNOVATIONSHFMKOALA EXTERNALREF-IPC-5000E141071

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-01-290

Event Narratives#

D

Patient 1

A KOALA INTRAUTERINE PRESSURE CATHETER (IUPC) DID NOT WORK PROPERLY ON PT. IT WOULD NOT SHOW CONTRACTIONS PROPERLY. IT WOULD NOT READ A BASELINE ABOVE 0. THE SAME PROBLEM OCCURRED ON TWO OTHER PTS USING IUPCS FROM THE SAME KOALA BOX.