MAUDE MDR 4275194

MDR report key: 4275194
Report number: 1018233-2014-00302
Event key: 0
Event type: 3
Date received: 2014-11-07
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 0
Health professional: 3
Initial report to FDA: 3
Event location: 0

Manufacturer Contact#

Contact: CHRISY 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	Y500	HUXA1441				R	N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2014-11-07	0	1. R

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT FOLLOWING SURGERY TO IMPLANT THE MESH, THE PT EXPERIENCED A SMALL BOWEL OBSTRUCTION. UNK CONSERVATIVE MANAGEMENT WAS ATTEMPTED AND WAS NOT SUCCESSFUL, THEREFORE THE PT HAD SURGERY ON (B)(6) 2014. IT WAS DISCOVERED AND A FEW LOOPS OF BOWEL WERE ADHERED BY THE MESH, REQUIRING RESECTION AND ANASTOMOSIS OF THE SMALL BOWEL. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

N

Patient 1

INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.

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 4275194

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

D

N

Related GUDID Devices By Product Code#

Related PMN/PMA Records By Product Code#