URETHRAL DILATOR SET 073701

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 2018-05-15 for URETHRAL DILATOR SET 073701 manufactured by Cook Inc.

Event Text Entries

[108360340] (b)(6). (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


[108360341] It was reported that a hair can be seen in the pouch which the urethral dilator set was packaged in. Therefore, the user didn't use the urethral dilator set as the sterilization may have been compromised. There were no adverse consequences to the patient as a result of this reported issue. The device did not make contact with the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1820334-2018-01474
MDR Report Key7515876
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-05-15
Date of Report2018-06-22
Date of Event2018-05-03
Date Mfgr Received2018-06-07
Device Manufacturer Date2018-01-31
Date Added to Maude2018-05-15
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 NameURETHRAL DILATOR SET
Generic NameKOE DILATOR, URETHRAL
Product CodeKOE
Date Received2018-05-15
Catalog Number073701
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 2018-05-15

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