KOALA UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2013-01-31 for KOALA UNKNOWN manufactured by Clinical Innovations, Inc..

Event Text Entries

[3225917] During a retrospective review of unexpected fetal outcomes in (b)(6) 2013 it is believed that the following iupc device may have caused or contributed to this fetal demise. Prior to delivery of a laboring patient on (b)(6) 2012, an iupc device was inserted into mother. This iupc device did not appear to be functioning appropriately and a 2nd iupc was deployed. Following this deployment fetal heart tones diminished and an emergent c-section was performed. Infant demise shortly after delivery. At the time of this event it was thought that the death was related to an atypical abruption. Subsequent investigation into this event along with pathology reports and laboratory values indicate that the iupc device may have caused a knick in a placental blood vessel, which may have contributed to a significant loss of fetal blood incompatible with life.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2944237
MDR Report Key2944237
Report Source99
Date Received2013-01-31
Date of Report2013-01-29
Date of Event2012-09-27
Date Facility Aware2012-12-31
Report Date2013-01-29
Date Reported to FDA2013-01-30
Date Reported to Mfgr2013-01-30
Date Added to Maude2013-02-05
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameKOALA
Generic NameINTRAUTERINE PRESSURE CATHETER
Product CodeHFN
Date Received2013-01-31
Model NumberUNKNOWN
Catalog NumberUNKNOWN
Lot NumberUNKNOWN
ID NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeNA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCLINICAL INNOVATIONS, INC.
Manufacturer Address747 WEST 4170 SOUTH MURRAY SALT LAKE CITY UT 84123 US 84123


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2013-01-31

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.