FASCIAL DILATOR 072016

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2018-08-29 for FASCIAL DILATOR 072016 manufactured by Cook Inc.

Event Text Entries

[118760629] (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


[118760630] It was reported, while checking their stock, the customer found a black dirt in 2 unopened, unused fascial dilator packages. No patient involvement.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1820334-2018-02616
MDR Report Key7828159
Report SourceFOREIGN,HEALTH PROFESSIONAL,O
Date Received2018-08-29
Date of Report2018-10-01
Date of Event2018-08-17
Date Mfgr Received2018-10-01
Device Manufacturer Date2018-02-26
Date Added to Maude2018-08-29
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 NameFASCIAL DILATOR
Generic NameKOE DILATOR, URETHRAL
Product CodeKOE
Date Received2018-08-29
Returned To Mfg2018-09-20
Catalog Number072016
Lot Number8625081
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 2018-08-29

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