COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS J-SOSR-100500

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 2018-02-21 for COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS J-SOSR-100500 manufactured by Cook Inc.

Event Text Entries

[100783640] (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


[100783641] It was reported the female patient was treated for post-partum hemorrhage using an inflated cook bakri postpartum balloon. As reported, the catheter was unable to be deflated by withdrawing water from the three-way tap. The three-way tap port was removed so the bakri could be deflated. The patient did not experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1820334-2018-00456
MDR Report Key7286634
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-02-21
Date of Report2018-05-03
Date of Event2018-01-18
Date Mfgr Received2018-04-26
Device Manufacturer Date2017-10-12
Date Added to Maude2018-02-21
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS
Generic NameKNA INSTRUMENT, MANUAL, SPECIALIZED, OBSTETRIC-GYNECOLOGIC
Product CodeKNA
Date Received2018-02-21
Catalog NumberJ-SOSR-100500
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOOK INC
Manufacturer Address750 DANIELS WAY BLOOMINGTON IN 47404 US 47404


Patients

Patient NumberTreatmentOutcomeDate
10 2018-02-21

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