MAUDE MDR 9842470

MDR report key: 9842470
Report number: 2210968-2020-02020
Event key: 0
Event type: 3
Date received: 2020-03-17
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: KARA DITTY-BOVARD
Address: P.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 08876 US
Phone: 610-610-6107
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	TOTAL PELVIC FLOOR REPAIR SYST	MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC	ETHICON INC.	OTP		PFRT01	1342884				R	N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2020-03-17	0	1. R

Event Narratives#

No narrative records found.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00814723020050	Elevate	ENDO PHARMACEUTICALS INC.	OTP	2015-10-24
00814723020067	Elevate	ENDO PHARMACEUTICALS INC.	OTP	2015-10-24
05708932459433	Exair	Coloplast A/S	OTP	2015-10-22
05708932459457	Exair	Coloplast A/S	OTP	2015-10-22
08714729839200	Uphold™ LITE	BOSTON SCIENTIFIC CORPORATION	OTP	2015-09-24

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K122459	OTP	PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM	Boston Scientific Corporation	2012-12-13
510(k)	K121612	OTP	ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION	American Medical Systems	2012-07-20
510(k)	K112842	OTP	AMS ELEVATE PC	American Medical Systems, Inc.	2011-10-25
510(k)	K103426	OTP	LITE PELVIC FLOOR REPAIR KITS	Boston Scientific Corp	2011-09-14
510(k)	K112386	OTP	EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM	Coloplast Corp.	2011-09-08