MAUDE MDR 8753877

MDR report key: 8753877
Report number: 2951238-2019-00984
Event key: 0
Event type: 3
Date of event: 2019-06-05
Date received: 2019-07-02
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: MS. CONNIE TUBERA
Address: 2400 RINGWOOD AVENUE SAN JOSE CA 95131 US
Phone: 408-408-4089
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	UROPASS AS 12/14FR X 54 CM 5/BX	UROPASS ACCESS SHEATH	TELEFLEX MEDICAL OEM	KNY	61254BX		09M1400190				Y	R

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2019-07-02	0

Event Narratives#

No narrative records found.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
10192253027648	Dover	Cardinal Health 200, LLC	KNY	2024-07-10
50192253032336	Dover	Cardinal Health 200, LLC	KNY	2024-07-10
50192253027646	Dover	Cardinal Health 200, LLC	KNY	2024-07-10
10192253032338	Dover	Cardinal Health 200, LLC	KNY	2024-07-10
03700512966197	Ureteral Access Sheath with 2, 3 Fr working channels dilator, 10 Fr x 35cm	Promepla	KNY	2017-11-09
03700512966203	Ureteral Access Sheath with 2, 3 Fr working channels dilator, 12 Fr x 35cm	Promepla	KNY	2017-11-09
03700512966210	Ureteral Access Sheath with 2, 3 Fr working channels dilator, 10Frx45cm	Promepla	KNY	2017-11-09
03700512966227	Ureteral Access Sheath with 2, 3 Fr working channels dilator, 12 Fr x 45cm	Promepla	KNY	2017-11-09
03700512986195	Ureteral Access Sheath with 2, 3 Fr working channels dilator, 10 Fr x 35cm	Promepla	KNY	2017-11-09
03700512986201	Ureteral Access Sheath with 2, 3 Fr working channels dilator, 12 Fr x 35cm	Promepla	KNY	2017-11-09
03700512986218	Ureteral Access Sheath with 2, 3 Fr working channels dilator, 10Frx45cm	Promepla	KNY	2017-11-09
03700512986225	Ureteral Access Sheath with 2, 3 Fr working channels dilator, 12 Fr x 45cm	Promepla	KNY	2017-11-09
00821925036345	VARI-PASS	Gyrus ACMI, LLC	KNY	2017-05-11
00821925027589	VARI-PASS 10/12 Fr (3.3/4mm) x 54CM	Gyrus Acmi, Inc.	KNY	2017-05-11
10680651445787	Halyard	Avanos Medical, Inc.	KNY	2017-05-10
00821925035393	UroPass	Gyrus ACMI, LLC	KNY	2016-10-12
00821925035409	UroPass	Gyrus ACMI, LLC	KNY	2016-10-12
00821925035423	UroPass	Gyrus ACMI, LLC	KNY	2016-10-12
00821925005976	UroPass Ureteral Access Sheath	Gyrus Acmi, Inc.	KNY	2016-10-12
00821925005983	UroPass Ureteral Access Sheath	Gyrus Acmi, Inc.	KNY	2016-10-12
00821925005990	UroPass Ureteral Access Sheath	Gyrus Acmi, Inc.	KNY	2016-10-12
00821925035317	UroPass	Gyrus ACMI, LLC	KNY	2016-10-03
00821925035324	GYRUS ACMI, INC	Gyrus ACMI, LLC	KNY	2016-10-03
00821925035331	UroPass	Gyrus ACMI, LLC	KNY	2016-10-03
00821925035348	UroPass	Gyrus ACMI, LLC	KNY	2016-10-03
00821925035355	UroPass	Gyrus ACMI, LLC	KNY	2016-10-03
00821925035362	UroPass	Gyrus ACMI, LLC	KNY	2016-10-03
00821925035379	UroPass	Gyrus ACMI, LLC	KNY	2016-10-03
00821925035386	UroPass	Gyrus ACMI, LLC	KNY	2016-10-03
00821925035416	UroPass	Gyrus ACMI, LLC	KNY	2016-10-03

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K182144	KNY	Bi-Flex Evo	Promepla Sam	2018-09-07
510(k)	K162356	KNY	Vesair Cystoscopic Sheath	Solace Therapeutics	2017-03-02
510(k)	K140441	KNY	BI-FLEX URETERAL ACCESS SHEATH	Promepla Sam	2014-06-17
510(k)	K140562	KNY	WIJAY EZ-VOID EXTERNAL CATHETER VALVE	Leomed, LLC	2014-06-16
510(k)	K141252	KNY	GUARDIAN URETHRAL SHEATH	Solace Therapeutics	2014-06-09

MAUDE MDR 8753877

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

Related GUDID Devices By Product Code#

Related PMN/PMA Records By Product Code#