KOALA IPC 5000 IPC-5000E

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-09-04 for KOALA IPC 5000 IPC-5000E manufactured by Clinical Innovation Inc..

Event Text Entries

[684774] Upon insertion of an internal uterine pressure catheter (iupc), vaginal bleeding occurred, and subsequent emergent c-section required. It is suspected that the inserted device contributed to a placental separation.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report NumberMW5003652
MDR Report Key908738
Date Received2007-09-04
Date of Event2007-08-12
Date Added to Maude2007-10-02
Event Key0
Report Source CodeVoluntary 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 FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameKOALA IPC 5000
Generic NameIUPS INTRA UTERINE PRESSURE SYSTEM
Product CodeHGS
Date Received2007-09-04
Model NumberIPC-5000E
Lot Number070448
ID Number5,573,007;5, 951,497:6,231,524
Device Expiration Date2009-05-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key893244
ManufacturerCLINICAL INNOVATION INC.
Manufacturer Address747 WEST 4170 SOUTH MURRAY UT 84123 US

Device Sequence Number: 2

Brand NameKOALA IPC 5000
Generic NameIUPS INTRA UTERINE PRESSURE SYSTEM
Product CodeHGS
Date Received2007-09-04
Device AvailabilityN
Implant FlagN
Date RemovedB
Device Sequence No2
Device Event Key893245
ManufacturerCLINICAL INNOVATION, INC
Manufacturer Address4170 SOUTH MURRAY UT 84123 US

Patients

Patient NumberTreatmentOutcomeDate
101. Other 2007-09-04
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