MAUDE MDR 3535677

MDR report key: 3535677
Report number: 1018233-2013-09717
Event key: 0
Event type: 3
Date received: 2013-12-13
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 600
Health professional: 3
Initial report to FDA: 3
Event location: 3

Manufacturer Contact#

Contact: CHRISTY LEWIS
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	ALYTE Y-MESH GRAFT		BARD SHANNON LIMITED	OTO	NA	Y100	HUV10782				R	N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2013-12-13	0	1. R

Event Narratives#

D

Patient 1

THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

N

Patient 1

THE SAMPLE WAS NOT RETURNED. THE FINISHED PRODUCT MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED FOR GENERAL DISTRIBUTION. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES ALL DEVICES CURRENTLY ADDRESSES POTENTIAL RISKS ASSOCIATED WITH SURGICALLY IMPLANTED MATERIALS. (B)(4). "LAWYER-FILED REPORT - (B)(4)".

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00890594000056	Desara Blue SL	Caldera Medical, Inc.	OTO	2022-08-03
00890594000070	Desara Blue SL	Caldera Medical, Inc.	OTO	2022-08-03
10705031202795	ARTISYN	Johnson & Johnson Medical GmbH	OTO	2019-01-29
00890594000339	Vertessa Lite 10x22cm	Caldera Medical, Inc.	OTO	2016-05-27
00890594000391	Vertessa Lite Strips 4x22cm	Caldera Medical, Inc.	OTO	2016-05-27
00890594000452	Vertessa Lite Y 22x5x4cm	Caldera Medical, Inc.	OTO	2016-05-27
00890594000704	Desara Blue OV	Caldera Medical, Inc.	OTO	2016-05-27
00890594000735	Desara Blue Short Suture Sling	Caldera Medical, Inc.	OTO	2016-05-27
00890594000643	Vertessa Lite 10x22cm	CALDERA MEDICAL, INC.	OTO	2016-05-27
00890594000360	Vertessa Lite 10x26cm	Caldera Medical, Inc.	OTO	2016-05-27
00890594000384	Vertessa Lite Strips 4x22cm	CALDERA MEDICAL, INC.	OTO	2016-05-27
00890594000421	Vertessa Lite Y-mesh 22x4x3cm	Caldera Medical, Inc.	OTO	2016-05-27
00890594000445	Vertessa Lite Y 22x5x4cm	CALDERA MEDICAL, INC.	OTO	2016-05-27
00890594000766	Desara SL	Caldera Medical, Inc.	OTO	2016-05-27
00890594000698	Desara Blue OV	CALDERA MEDICAL, INC.	OTO	2016-05-27
00890594000728	Desara Blue Short Suture Sling	CALDERA MEDICAL, INC.	OTO	2016-05-27
00089059400766	Desara SL	CALDERA MEDICAL, INC.	OTO	2016-05-27
00890594000674	Desara Blue	Caldera Medical, Inc.	OTO	2016-05-26
00890594000797	Vertessa Lite Y-Mesh 26x5x4cm	Caldera Medical, Inc.	OTO	2015-10-30
00890594000483	Vertessa Lite Y-Mesh 26x4x3cm	Caldera Medical, Inc.	OTO	2015-10-30
00890594000773	Vertessa Lite Y-Mesh 26x5x4cm	CALDERA MEDICAL, INC.	OTO	2015-10-30
05708932483223	Restorelle	Coloplast A/S	OTO	2015-10-24
00814723020333	IntePro Y-Mesh	ENDO PHARMACEUTICALS INC.	OTO	2015-10-24
05708932483285	Restorelle	Coloplast A/S	OTO	2015-10-22
05708932483834	Restorelle	Coloplast A/S	OTO	2015-10-22
05708932483896	Restorelle	Coloplast A/S	OTO	2015-10-22
05708932483964	Restorelle	Coloplast A/S	OTO	2015-10-22
05708932528108	Restorelle	Coloplast A/S	OTO	2015-10-22
05708932553773	Coloplast	Coloplast A/S	OTO	2015-10-22
08714729839217	Upsylon™	BOSTON SCIENTIFIC CORPORATION	OTO	2015-09-24

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K171271	OTO	Polyform Synthetic Mesh	Boston Scientific Corporation	2017-12-15
510(k)	K150023	OTO	Vertessa Lite Y-Mesh	Caldera Medical, Inc.	2015-04-06
510(k)	K150016	OTO	Vertessa Lite	Caldera Medical, Inc.	2015-04-06
510(k)	K140116	OTO	RESTORELLE Y CONTOUR MESH	Coloplast A/S	2014-02-12
510(k)	K132061	OTO	RESTORELLE M, RESTORELLE XL	Coloplast Corp.	2013-08-02

MAUDE MDR 3535677

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

D

N

Related GUDID Devices By Product Code#

Related PMN/PMA Records By Product Code#