MAUDE MDR 8816235

MDR report key: 8816235
Report number: 1820334-2019-01759
Event key: 0
Event type: 3
Date of event: 2019-07-08
Date received: 2019-07-23
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
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	FLEXOR URETERAL ACCESS SHEATH AND DILATORS	EZN DILATOR, CATHETER, URETERAL	COOK INC	EZN	G46168	FUS-120045	9447677				R	Y

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2019-07-23	0

Event Narratives#

No narrative records found.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
03600040975312	Coloplast	Coloplast A/S	EZN	2024-07-09
03600040975343	Coloplast	Coloplast A/S	EZN	2024-07-09
03600040975336	Coloplast	Coloplast A/S	EZN	2024-07-09
03600040975367	Coloplast	Coloplast A/S	EZN	2024-07-09
03600040911051	Coloplast	Coloplast A/S	EZN	2024-05-21
03600040911082	Coloplast	Coloplast A/S	EZN	2024-05-21
03600040953792	Coloplast	Coloplast A/S	EZN	2024-05-21
03600040911068	Coloplast	Coloplast A/S	EZN	2024-05-21
03600040911105	Coloplast	Coloplast A/S	EZN	2024-05-21
03600040953808	Coloplast	Coloplast A/S	EZN	2024-05-21
03600040953761	Coloplast	Coloplast A/S	EZN	2024-05-10
03600040953785	Coloplast	Coloplast A/S	EZN	2024-05-10
03600040953679	Coloplast	Coloplast A/S	EZN	2024-04-12
03600040953709	Coloplast	Coloplast A/S	EZN	2024-04-12
03600040953730	Coloplast	Coloplast A/S	EZN	2024-04-12
03600040953693	Coloplast	Coloplast A/S	EZN	2024-04-12
03600040953716	Coloplast	Coloplast A/S	EZN	2024-04-12
03600040953747	Coloplast	Coloplast A/S	EZN	2024-04-12
00812261012605	ARMADA	ALLWIN MEDICAL DEVICES, INC.	EZN	2023-07-31
00812261012612	ARMADA	ALLWIN MEDICAL DEVICES, INC.	EZN	2023-07-31
10812261012602	ARMADA	ALLWIN MEDICAL DEVICES, INC.	EZN	2023-07-31
10812261012619	ARMADA	ALLWIN MEDICAL DEVICES, INC.	EZN	2023-07-31
03600040325117	Porges Coloplast	Coloplast A/S	EZN	2020-06-19
03600040325148	Porges Coloplast	Coloplast A/S	EZN	2020-06-19
03600040325179	Porges Coloplast	Coloplast A/S	EZN	2020-06-19
05708932727501	Porges Coloplast	Coloplast A/S	EZN	2020-06-19
05708932727532	Porges Coloplast	Coloplast A/S	EZN	2020-06-19
05708932727563	Porges Coloplast	Coloplast A/S	EZN	2020-06-19
00810116021383	Dornier MedTech	DORNIER MEDTECH AMERICA, INC.	EZN	2020-02-25
00810116021390	Dornier MedTech	DORNIER MEDTECH AMERICA, INC.	EZN	2020-02-25

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K250910	EZN	Optilume® High Pressure Urological Balloon Dilation Catheter	Urotronic, Inc.	2025-05-22
510(k)	K220781	EZN	ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter	Allwin Medical Devices, Inc.	2023-05-05
510(k)	K201007	EZN	In-Ka Ureteral Balloon Dilatation Catheter	Coloplast Corp.	2020-06-11
510(k)	K190612	EZN	EQUINOX Balloon Dilatation Catheter	Dornier Medtech America, Inc.	2019-12-06
510(k)	K173654	EZN	Ureteral Dilator Sets, Ureteral Dilators	Cook Incorporated	2018-07-17

MAUDE MDR 8816235

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

Related GUDID Devices By Product Code#

Related PMN/PMA Records By Product Code#