BAKRI TAMPONADE BALLOON CATHETER G30673 J-SOS-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 2020-01-30 for BAKRI TAMPONADE BALLOON CATHETER G30673 J-SOS-100500 manufactured by Cook Inc.

Event Text Entries

[177368598] (b)(6). Occupation: agent. 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


[177368599] It was reported, the patient received hemabate, oxytocin and uterus massage to treat postpartum hemorrhage (pph). A bakri tamponade balloon catheter was placed and the bleeding did not improve. The bakri was removed from the patient and they discovered the balloon was leaking through a pinhole. Another same type device was used to complete the procedure. No adverse events have been reported as a result of the alleged malfunction. Additional information has been requested regarding the patient and the event. At the time of this report, no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1820334-2020-00238
MDR Report Key9646395
Report SourceDISTRIBUTOR,FOREIGN,OTHER,USE
Date Received2020-01-30
Date of Report2020-03-13
Date of Event2020-01-15
Date Mfgr Received2020-03-13
Device Manufacturer Date2019-07-23
Date Added to Maude2020-01-30
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 NameBAKRI TAMPONADE BALLOON CATHETER
Generic NameOQY INTRAUTERINE BALLOON
Product CodeOQY
Date Received2020-01-30
Returned To Mfg2020-03-09
Model NumberG30673
Catalog NumberJ-SOS-100500
Lot Number9897231
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 2020-01-30

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