BALLOON UTERINE STENT J-BUS-253000

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 2019-01-03 for BALLOON UTERINE STENT J-BUS-253000 manufactured by Cook Inc.

Event Text Entries

[132088262] (b)(6). 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


[132088263] It is reported that while preparing for an unspecified procedure using a balloon uterine stent, the end user opened the package to inspect the device prior to use and found an unknown black stain on the balloon. This device was not used. No adverse events have been reported as a result of the alleged malfunction.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1820334-2019-00038
MDR Report Key8214403
Report SourceDISTRIBUTOR,FOREIGN,OTHER,USE
Date Received2019-01-03
Date of Report2019-02-11
Date of Event2019-01-02
Date Mfgr Received2019-02-08
Device Manufacturer Date2018-08-01
Date Added to Maude2019-01-03
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 ContactMR. LARRY POOL
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 NameBALLOON UTERINE STENT
Generic NameKNA INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC
Product CodeKNA
Date Received2019-01-03
Returned To Mfg2019-01-17
Catalog NumberJ-BUS-253000
Lot Number9060688
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 2019-01-03

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