BAKRI TAMPONADE BALLOON CATHETER J-SOS-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 2018-01-26 for BAKRI TAMPONADE BALLOON CATHETER J-SOS-100500 manufactured by Cook Inc.

Event Text Entries

[98348224] (b)(4). This mdr is being filed after the associated complaint was reviewed under remediation protocol cap008, complaint/mdr retrospective review and remediation and reassessed as reportable. Additional complaint investigation and record remediation was not performed.
Patient Sequence No: 1, Text Type: N, H10


[98348225] It was reported that after insertion of the balloon, it was found to be leaking from a micro-puncture. There were no other balloons available, so the patient required a blood transfusion and transfer to another level of care. There were no other injuries reported, and no pieces of the device remained in the patient's body.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1820334-2018-00269
MDR Report Key7221386
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-01-26
Date of Report2018-01-26
Date of Event2015-05-30
Date Mfgr Received2018-01-22
Device Manufacturer Date2015-03-30
Date Added to Maude2018-01-26
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 Phone8128294891
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBAKRI TAMPONADE BALLOON CATHETER
Generic NameKNA INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC
Product CodeKNA
Date Received2018-01-26
Catalog NumberJ-SOS-100500
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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
101. Required No Informationntervention 2018-01-26

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