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 2017-12-27 for COOK CERVICAL RIPENING BALLOON W/STYLET J-CRBS-184000 manufactured by Cook Inc.

Event Text Entries

[96069818] (b)(4). The event is currently under investigation. A follow up report will be submitted upon receipt of additional information or completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10


[96069819] I was reported that the stylet pierced the distal tip of the catheter of a cook cervical ripening balloon w/stylet. The patient went on to have a natural labor. No known adverse event was reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1820334-2017-04342
MDR Report Key7148473
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2017-12-27
Date of Report2018-03-06
Date of Event2017-12-07
Date Mfgr Received2018-02-06
Device Manufacturer Date2017-09-25
Date Added to Maude2017-12-27
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
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 Received2017-12-27
Catalog NumberJ-CRBS-184000
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCOOK INC
Manufacturer Address750 DANIELS WAY BLOOMINGTON IN 47404 US 47404


Patients

Patient NumberTreatmentOutcomeDate
10 2017-12-27

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