FDA Adverse Event Injury Summary report: N

MENTOR MEMORYGEL BREAST IMPLANT

MDR report key: 9290824 · Received November 7, 2019

Report

Report Number: 1645337-2019-23310
Event Type: Injury
Date Received: November 7, 2019
Date of Event: July 30, 2019
Report Date: October 17, 2019
Manufacturer: MENTOR TEXAS
Product Code: FTR
UDI-DI: 00081317000280
PMA / PMN Number: P030053
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

SINCE THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS CAN BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, THE INVESTIGATION WILL BE REOPENED AND CONDUCTED AS APPROPRIATE. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: CAPSULAR CONTRACTURE. CONCOMITANT PRODUCTS: A MENTOR MEMORYGEL BREAST IMPLANT 300CC , CATALOG NUMBER 3503501BC, SERIAL NUMBER (B)(4), LOT NUMBER 6844068 MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL BREAST IMPLANT 300CC AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE III ON THE LEFT BREAST IMPLANT. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 450CC ON (B)(6) 2019.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1084406	MENTOR MEMORYGEL BREAST IMPLANT	PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED	FTR	MENTOR TEXAS		6854027	00081317000280

Patients

Seq	Age	Sex	Outcome	Treatment
1	31 YR		Required Intervention