MAUDE MDR 9392291

MDR report key: 9392291
Report number: 1645337-2019-24753
Event key: 0
Event type: 3
Date of event: 2019-09-13
Date received: 2019-11-30
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: MR. GABRIEL ALFAGEME
Address: 3041 SKYWAY CIRCLE NORTH IRVING TX 75038 US
Phone: 949-949-9497
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	MENTOR MEMORYGEL BREAST IMPLANT	PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED	MENTOR TEXAS	FTR		3505650BC	7630431				N	N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2019-11-30	0	1. O

Event Narratives#

No narrative records found.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
07445161001702	Motiva® SmoothSilk® Round Breast Implant	Establishment Labs S.A.	FTR	2024-10-04
07445161001719	Motiva® SmoothSilk® Round Breast Implant	Establishment Labs S.A.	FTR	2024-10-04
07445161001726	Motiva® SmoothSilk® Round Breast Implant	Establishment Labs S.A.	FTR	2024-10-04
07445161001733	Motiva® SmoothSilk® Round Breast Implant	Establishment Labs S.A.	FTR	2024-10-04
07445161001740	Motiva® SmoothSilk® Round Breast Implant	Establishment Labs S.A.	FTR	2024-10-04
07445161001757	Motiva® SmoothSilk® Round Breast Implant	Establishment Labs S.A.	FTR	2024-10-04
07445161001764	Motiva® SmoothSilk® Round Breast Implant	Establishment Labs S.A.	FTR	2024-10-04
07445161001849	Motiva® SmoothSilk® Round Breast Implant	Establishment Labs S.A.	FTR	2024-10-04
07445161001856	Motiva® SmoothSilk® Round Breast Implant	Establishment Labs S.A.	FTR	2024-10-04
07445161001863	Motiva® SmoothSilk® Round Breast Implant	Establishment Labs S.A.	FTR	2024-10-04
07445161001870	Motiva® SmoothSilk® Round Breast Implant	Establishment Labs S.A.	FTR	2024-10-04
07445161001887	Motiva® SmoothSilk® Round Breast Implant	Establishment Labs S.A.	FTR	2024-10-04
07445161001894	Motiva® SmoothSilk® Round Breast Implant	Establishment Labs S.A.	FTR	2024-10-04
07445161001900	Motiva® SmoothSilk® Round Breast Implant	Establishment Labs S.A.	FTR	2024-10-04
07445161001917	Motiva® SmoothSilk® Round Breast Implant	Establishment Labs S.A.	FTR	2024-10-04
07445161001924	Motiva® SmoothSilk® Round Breast Implant	Establishment Labs S.A.	FTR	2024-10-04
07445161001931	Motiva® SmoothSilk® Round Breast Implant	Establishment Labs S.A.	FTR	2024-10-04
07445161001948	Motiva® SmoothSilk® Round Breast Implant	Establishment Labs S.A.	FTR	2024-10-04
07445161001955	Motiva® SmoothSilk® Round Breast Implant	Establishment Labs S.A.	FTR	2024-10-04
07445161001962	Motiva® SmoothSilk® Round Breast Implant	Establishment Labs S.A.	FTR	2024-10-04
07445161001979	Motiva® SmoothSilk® Round Breast Implant	Establishment Labs S.A.	FTR	2024-10-04
07445161002051	Motiva® SmoothSilk® Round Breast Implant	Establishment Labs S.A.	FTR	2024-10-04
07445161002068	Motiva® SmoothSilk® Round Breast Implant	Establishment Labs S.A.	FTR	2024-10-04
07445161002075	Motiva® SmoothSilk® Round Breast Implant	Establishment Labs S.A.	FTR	2024-10-04
07445161002082	Motiva® SmoothSilk® Round Breast Implant	Establishment Labs S.A.	FTR	2024-10-04
07445161002099	Motiva® SmoothSilk® Round Breast Implant	Establishment Labs S.A.	FTR	2024-10-04
07445161002105	Motiva® SmoothSilk® Round Breast Implant	Establishment Labs S.A.	FTR	2024-10-04
07445161002112	Motiva® SmoothSilk® Round Breast Implant	Establishment Labs S.A.	FTR	2024-10-04
07445161002129	Motiva® SmoothSilk® Round Breast Implant	Establishment Labs S.A.	FTR	2024-10-04
07445161002136	Motiva® SmoothSilk® Round Breast Implant	Establishment Labs S.A.	FTR	2024-10-04

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
PMA	P060028S058	FTR	MENTOR™ MemoryShape™ Breast Implants	Mentor Worldwide, LLC	2026-07-21
PMA	P030053S085	FTR	MENTOR™ MemoryGel™ Breast Implants	Mentor Corp.	2026-07-21
PMA	P030053S083	FTR	MENTOR™ MemoryGel™ Enhance Breast Implants	Mentor Corp.	2026-05-11
PMA	P030053S089	FTR	MENTOR™ MemoryGel™ Silicone Gel-Filled Breast Implants	Mentor Corp.	2026-05-01
PMA	P030053S088	FTR	MemoryGel Silicone Gel-Filled Breast Implant	Mentor Corp.	2026-04-30

MAUDE MDR 9392291

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

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