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 company representative,foreig report with the FDA on 2020-02-12 for COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS G24237 J-SOSR-100500 manufactured by Cook Inc.

MAUDE Entry Details

Report Number1820334-2020-00330
MDR Report Key9699149
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-02-12
Date of Report2020-02-24
Date Mfgr Received2020-02-20
Device Manufacturer Date2019-10-10
Date Added to Maude2020-02-12
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 Received2020-02-12
Model NumberG24237
Catalog NumberJ-SOSR-100500
Lot Number10073070
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOOK INC
Manufacturer Address750 DANIELS WAY BLOOMINGTON IN 47404 US 47404


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-12

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