COOK G19891 J-CRBS-184000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-26 for COOK G19891 J-CRBS-184000 manufactured by Cook Incorporated.

Event Text Entries

[112414313] A cook catheter was being placed when stylet was felt through the tip. The cook catheter was taken out and saved with the packaging.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number7639048
MDR Report Key7639048
Date Received2018-06-26
Date of Report2018-06-05
Date of Event2018-06-01
Report Date2018-06-05
Date Reported to FDA2018-06-05
Date Reported to Mfgr2018-06-25
Date Added to Maude2018-06-26
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOOK
Generic NameCATHETER, BALLOON, DILATION OF CERVICAL CANAL PRIOR TO LABOR
Product CodePFJ
Date Received2018-06-26
Model NumberG19891
Catalog NumberJ-CRBS-184000
Lot Number8838141
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOOK INCORPORATED
Manufacturer Address750 DANIELS WAY BLOOMINGTON IN 47404 US 47404


Patients

Patient NumberTreatmentOutcomeDate
10 2018-06-26

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