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

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-05-24 for COOK CERVICAL RIPENING BALLOON W/STYLET J-CRBS-184000 manufactured by Cook Inc.

Event Text Entries

[146090387] (b)(6). Occupation: midwife. (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


[146090388] It is reported during labor induction using a cook cervical ripening balloon w/stylet for pre-induction in an outpatient setting, an unspecified number of patients have experienced transverse lie and/or umbilical cord prolapse. No product malfunction was reported. No additional consequences to the patients have reported. Additional information has been requested to clarify number of patients involved, as well as patient/event details. At this time, no additional information has been provided
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1820334-2019-01262
MDR Report Key8641150
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-05-24
Date of Report2019-07-01
Date Mfgr Received2019-06-07
Date Added to Maude2019-05-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 Received2019-05-24
Catalog NumberJ-CRBS-184000
Lot NumberUNKNOWN
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. Other 2019-05-24

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