COOK CERVICAL RIPENING BALLOON 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 2019-07-02 for COOK CERVICAL RIPENING BALLOON G19891 J-CRBS-184000 manufactured by Cook Incorporated.

MAUDE Entry Details

Report NumberMW5087736
MDR Report Key8754002
Date Received2019-07-02
Date of Report2019-06-28
Date of Event2019-05-10
Date Added to Maude2019-07-02
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
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 CERVICAL RIPENING BALLOON
Generic NameCATHETER, BALLOON, DILATION OF CERVICAL CANAL PRIOR TO LABOR
Product CodePFJ
Date Received2019-07-02
Model NumberG19891
Catalog NumberJ-CRBS-184000
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerCOOK INCORPORATED
Manufacturer AddressBLOOMINGTON IN 46704 US 46704


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2019-07-02

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