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,user f report with the FDA on 2018-02-22 for COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS J-SOSR-100500 manufactured by Cook Inc.

Event Text Entries

[100912846] (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


[100912847] It was reported sometime in (b)(6) 2017 they used the cook bakri postpartum balloon with rapid instillation components after a c-section. They placed the balloon fine, but later found the blue stop cock in the patients uterus. No further information has been provided. Additional patient, device and event information has been requested but not received at the time of this report.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1820334-2018-00461
MDR Report Key7289306
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2018-02-22
Date of Report2018-04-23
Date Mfgr Received2018-04-13
Date Added to Maude2018-02-22
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 BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS
Generic NameKNA INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC
Product CodeKNA
Date Received2018-02-22
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 2018-02-22

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