MAUDE MDR 8932146

MDR report key: 8932146
Report number: 1018233-2019-05101
Event key: 0
Event type: 3
Date of event: 2019-08-09
Date received: 2019-08-26
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 3
Health professional: 3
Initial report to FDA: 3
Event location: 3

Manufacturer Contact#

Contact: YONIC ANDERSON
Address: 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US
Phone: 770-770-7707
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	BARDEX? LUBRICATH? FOLEY CATHETER	FOLEY CATHETER (LATEX)	C.R. BARD, INC. (COVINGTON) -1018233	EZC		0165L14	MYDP6112				Y	R

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2019-08-26	0

Event Narratives#

No narrative records found.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
14026704942456	RUSCH	TELEFLEX INCORPORATED	EZC	2026-05-15
14026704942463	RUSCH	TELEFLEX INCORPORATED	EZC	2026-05-15
14026704942470	RUSCH	TELEFLEX INCORPORATED	EZC	2026-05-15
14026704942487	RUSCH	TELEFLEX INCORPORATED	EZC	2026-05-15
14026704942494	RUSCH	TELEFLEX INCORPORATED	EZC	2026-05-15
14026704942500	RUSCH	TELEFLEX INCORPORATED	EZC	2026-05-15
14026704942517	RUSCH	TELEFLEX INCORPORATED	EZC	2026-05-15
10854913006195	Urinary Catheter, 16 Fr	UROGEN PHARMA LTD	EZC	2025-11-17
10854913006157	Urinary Catheter, 16 Fr	UROGEN PHARMA LTD	EZC	2025-11-16
10854913006119	Urinary Catheter	UROGEN PHARMA LTD	EZC	2022-06-01
10854913006126	Urinary Catheter	UROGEN PHARMA LTD	EZC	2022-06-01
10852141007731	COMPACTCATH - Lite	COMPACTCATH, INC.	EZC	2019-09-01
00801741040665	Bardex® Lubricath® Hydrogel-Coated Foley Catheter Kit	C. R. Bard, Inc.	EZC	2016-08-16
00801741040672	Bardex® Lubricath® Hydrogel-Coated Foley Catheter Kit	C. R. Bard, Inc.	EZC	2016-08-16
00801741040689	Bardex® Lubricath® Hydrogel-Coated Foley Catheter Kit	C. R. Bard, Inc.	EZC	2016-08-16
00801741040696	Bardex® Lubricath® Hydrogel-Coated Foley Catheter Kit	C. R. Bard, Inc.	EZC	2016-08-16
00801741040702	Bardex® Lubricath® Hydrogel-Coated Foley Catheter Kit	C. R. Bard, Inc.	EZC	2016-08-16
00801741040719	Bardex® Lubricath® Hydrogel-Coated Foley Catheter Kit	C. R. Bard, Inc.	EZC	2016-08-16
00801741046520	Bardex® Silicone Elastomer-Coated Foley Catheter Kit	C. R. Bard, Inc.	EZC	2016-08-16
00801741046537	Bardex® Silicone Elastomer-Coated Foley Catheter Kit	C. R. Bard, Inc.	EZC	2016-08-16
00801741046544	Bardex® Silicone Elastomer-Coated Foley Catheter Kit	C. R. Bard, Inc.	EZC	2016-08-16
00801741046551	Bardex® Silicone Elastomer-Coated Foley Catheter Kit	C. R. Bard, Inc.	EZC	2016-08-16
00801741046568	Bardex® Silicone Elastomer-Coated Foley Catheter Kit	C. R. Bard, Inc.	EZC	2016-08-16
00801741046575	Bardex® Silicone Elastomer-Coated Foley Catheter Kit	C. R. Bard, Inc.	EZC	2016-08-16
00801741046582	Bardex® Silicone Elastomer-Coated Foley Catheter Kit	C. R. Bard, Inc.	EZC	2016-08-16
00801741046599	Bardex® Silicone Elastomer-Coated Foley Catheter Kit	C. R. Bard, Inc.	EZC	2016-08-16
00801741017735	Bardex® Lubricath® Foley Catheter	C. R. Bard, Inc.	EZC	2016-08-06
00801741017742	Bardex® Lubricath® Foley Catheter	C. R. Bard, Inc.	EZC	2016-08-06
00801741017759	Bardex® Lubricath® Foley Catheter	C. R. Bard, Inc.	EZC	2016-08-06
00801741019333	Bard® CritiCore® Surgipack® with Bardex® LubriCath® Temp Sensing Catheter	C. R. Bard, Inc.	EZC	2016-08-06

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K222279	EZC	Rusch Intermittent Urethral Catheters	Teleflex Medical	2022-08-29
510(k)	K173596	EZC	Rusch Intermittent Urethral Catheters	Teleflex Medical	2018-01-29
510(k)	K946282	EZC	UNIVERSAL URETHRAL CATHETER	Louisville Laboratories, Inc.	1995-03-31
510(k)	K913341	EZC	BARD(R) COUDE TIP TEMPERATURE SENSING CATHETER	C.R. Bard, Inc.	1992-01-27
510(k)	K910846	EZC	BARD LATEX URINARY CATHETERS DRAINS- DESIGNS MODIF	C.R. Bard, Inc.	1991-08-16

MAUDE MDR 8932146

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Patients#

Event Narratives#

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