COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS G24237 J-SOSR-100500

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,other,use report with the FDA on 2020-03-03 for COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS G24237 J-SOSR-100500 manufactured by Cook Inc.

Event Text Entries

[182931426] Pma/510k # k170622. 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


[182931427] It was reported that after a natural delivery a patient experienced a post-partum hemorrhage (pph) and a cook bakri postpartum balloon with rapid instillation components was placed, but was found to leak. After the pph was discovered, contraction medication was used to treat, but it did not work and the patient had lost 1100 ml of blood by this point. The bakri balloon was then placed and was being inflated, but once the inflation volume reached 400 ml liquid was found to be leaking from the vagina. The device was then deflated, removed, and a leak was found at the inflation valve joint. Another device was used to reach hemostasis. It was reported that the patient did not experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1820334-2020-00530
MDR Report Key9779974
Report SourceDISTRIBUTOR,FOREIGN,OTHER,USE
Date Received2020-03-03
Date of Report2020-04-01
Date of Event2020-02-18
Date Mfgr Received2020-03-27
Device Manufacturer Date2018-05-01
Date Added to Maude2020-03-03
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 ContactMRS. JENNIFER CANADA
Manufacturer Street750 DANIELS WAY
Manufacturer CityBLOOMINGTON IN 47404
Manufacturer CountryUS
Manufacturer Postal47404
Manufacturer Phone8123392235
Manufacturer G1COOK INC
Manufacturer Street750 DANIELS WAY
Manufacturer CityBLOOMINGTON IN 47404
Manufacturer CountryUS
Manufacturer Postal Code47404
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS
Generic NameOQY INTRAUTERINE BALLOON
Product CodeOQY
Date Received2020-03-03
Returned To Mfg2020-03-19
Model NumberG24237
Catalog NumberJ-SOSR-100500
Lot Number8853108
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
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 2020-03-03

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