MAUDE MDR 9391684

MDR report key: 9391684
Report number: 9617229-2019-20999
Event key: 0
Event type: 3
Date of event: 2018-10-01
Date received: 2019-11-29
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 0
Health professional: 0
Initial report to FDA: 0
Event location: 3

Manufacturer Contact#

Contact: MRS. MICHELLE BURGESS
Address: 301 W HOWARD LANE SUITE 100 AUSTIN TX 78753 US
Phone: 737-737-7372
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	STYLE 15 SILICONE GEL FILLED BREAST IMPLANT	PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED	ALLERGAN (COSTA RICA)	FTR		15-533	2032322				R	N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2019-11-29	0	1. R

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 9391684

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

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Related PMN/PMA Records By Product Code#