COOK CERVICAL RIPENING BALLOON W/STYLET G19891 J-CRBS-184000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,study,user faci report with the FDA on 2019-05-15 for COOK CERVICAL RIPENING BALLOON W/STYLET G19891 J-CRBS-184000 manufactured by Cook Inc.

Event Text Entries

[145167441] (b)(6). Occupation: other healthcare professional-study coordinator. (b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10


[145167442] It is reported in a study of labor induction methods, the patient was randomized to induction using cook cervical ripening balloon w/stylet. The patient required a vacuum assisted vaginal delivery using a kiwi. Following delivery, the patient lost 1. 2 liters of blood. The patient was given tranexamic acid, syntocinon, and syntometrine to treat the post partum hemorrhage with resolution. The patient's hospital stay was prolonged due to the vacuum assisted vaginal delivery and post-partum hemorrhage. The provider (principal investigator) reported that there is no causal relationship between the cook cervical ripening balloon and the vacuum assisted vaginal delivery and subsequent post-partum hemorrhage. No additional consequences have been reported as occurring. Additional details have been requested regarding the patient and the event. At this time, no additional information has been provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1820334-2019-01042
MDR Report Key8613184
Report SourceFOREIGN,OTHER,STUDY,USER FACI
Date Received2019-05-15
Date of Report2019-05-24
Date of Event2019-01-13
Date Mfgr Received2019-05-17
Device Manufacturer Date2018-11-15
Date Added to Maude2019-05-15
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. LARRY POOL
Manufacturer Street750 DANIELS WAY
Manufacturer CityBLOOMINGTON IN 47404
Manufacturer CountryUS
Manufacturer Postal47404
Manufacturer Phone8123392235
Manufacturer G1COOK INC
Manufacturer Street750 DANIELS WAY
Manufacturer CityBLOOMINGTON IN 47404
Manufacturer CountryUS
Manufacturer Postal Code47404
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOOK CERVICAL RIPENING BALLOON W/STYLET
Generic NamePFJ, DILATOR, CERVICAL, HYGROSCOPIC-IAMINARIA
Product CodePFJ
Date Received2019-05-15
Model NumberG19891
Catalog NumberJ-CRBS-184000
Lot Number9313833
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOOK INC
Manufacturer Address750 DANIELS WAY BLOOMINGTON IN 47404 US 47404


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Other 2019-05-15

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