URETHRAL DILATION BALLOON CATHETER G17843 UDBS-090029-FF

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 2018-02-08 for URETHRAL DILATION BALLOON CATHETER G17843 UDBS-090029-FF manufactured by Cook Inc.

Event Text Entries

[99805617] (b)(4). 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


[99805618] It was reported upon opening the packaging of the urethral dilation balloon catheter, the balloon was not equipped with the filiform tip. The filiform tip was not in the packaging. The urethra dilatation procedure to treat urethra strictures in a male patient was unable to proceed further because of the missing filiform tip. As reported there were no adverse consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1820334-2018-00224
MDR Report Key7251838
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-02-08
Date of Report2018-06-08
Date of Event2018-01-30
Date Mfgr Received2018-06-05
Device Manufacturer Date2016-10-04
Date Added to Maude2018-02-08
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameURETHRAL DILATION BALLOON CATHETER
Generic NameKOE DILATOR, URETHRAL
Product CodeKOE
Date Received2018-02-08
Model NumberG17843
Catalog NumberUDBS-090029-FF
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
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 2018-02-08

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