MAUDE MDR 8759795

MDR report key: 8759795
Report number: 1820334-2019-01606
Event key: 0
Event type: 3
Date received: 2019-07-03
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 0
Health professional: 3
Initial report to FDA: 3
Event location: 3

Manufacturer Contact#

Contact: MR. LARRY POOL
Address: 750 DANIELS WAY BLOOMINGTON IN 47404 US
Phone: 812-812-8123
Report source: M
Manufacturer link flag: Y

Devices#

Seq, Brand, Generic table
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	OPEN-END FLEXI-TIP URETERAL CATHETER	GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY	COOK INC	GBL	G14521	021305	9738671				R	Y

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2019-07-03	0

Event Narratives#

No narrative records found.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00827002161542	Cook	COOK INCORPORATED	GBL	2016-11-04
00827002161559	Cook	COOK INCORPORATED	GBL	2016-11-04
00827002161566	Cook	COOK INCORPORATED	GBL	2016-11-04
00827002161573	Cook	COOK INCORPORATED	GBL	2016-11-04
00827002161580	Cook	COOK INCORPORATED	GBL	2016-11-04
00827002169807	Cook	COOK INCORPORATED	GBL	2016-11-04
00827002170056	Cook	COOK INCORPORATED	GBL	2016-11-04
00827002147034	Cook	COOK INCORPORATED	GBL	2016-11-04
00827002147775	Cook	COOK INCORPORATED	GBL	2016-11-04
00827002147782	Cook	COOK INCORPORATED	GBL	2016-11-04
00827002172371	Round Tip	COOK INCORPORATED	GBL	2016-10-06
00827002148703	Cook	COOK INCORPORATED	GBL	2016-09-30
00827002140271	Flexi-Tip	COOK INCORPORATED	GBL	2016-09-24
00827002140325	Whistle Tip	COOK INCORPORATED	GBL	2016-09-24
00827002140332	Whistle Tip	COOK INCORPORATED	GBL	2016-09-24
00827002140400	Whistle Tip	COOK INCORPORATED	GBL	2016-09-24
00827002140417	Whistle Tip	COOK INCORPORATED	GBL	2016-09-24
00827002140530	Round Tip	COOK INCORPORATED	GBL	2016-09-24
00827002148741	Cook	COOK INCORPORATED	GBL	2016-09-24
00827002150362	Cook	COOK INCORPORATED	GBL	2016-09-24
00827002158597	Whistle Tip	COOK INCORPORATED	GBL	2016-09-24
00827002159402	Cook	COOK INCORPORATED	GBL	2016-09-24
00827002167926	Flexi-Tip	COOK INCORPORATED	GBL	2016-09-24
00827002171602	Cook	COOK INCORPORATED	GBL	2016-09-24
00827002172623	Whistle Tip	COOK INCORPORATED	GBL	2016-09-24
00827002178199	Cook	COOK INCORPORATED	GBL	2016-09-24
00827002179158	Flexi-Tip	COOK INCORPORATED	GBL	2016-09-24
00827002187900	Flexi-Tip	COOK INCORPORATED	GBL	2016-09-24
00827002188839	Cook	COOK INCORPORATED	GBL	2016-09-24
10827002140148	Flexi-Tip	COOK INCORPORATED	GBL	2016-09-24

MAUDE MDR 8759795

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

Related GUDID Devices By Product Code#