BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 7607485 · Received June 15, 2018

    Report

    Report Number
    1645337-2018-03707
    Event Type
    Injury
    Date Received
    June 15, 2018
    Date of Event
    January 22, 2017
    Report Date
    May 21, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000143
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED ON 6/25/2018, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE HAS BEEN DISCARDED. AS A RESULT, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. A DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: LEFT MENTOR MEMORYGEL BREAST IMPLANT 450CC GEL PROTHESIS, CATALOG: 3507450BC, LOT: 1001338. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT WHO UNDERWENT BREAST PROSTHESES IMPLANTATION WITH MENTOR MEMORYGEL BREAST IMPLANT 450CC GEL PROTHESES IN 2005 PRESENTED WITH RIGHT BREAST PAIN, HARDNESS AND SHIFT IN POSITION. THE PATIENT HAD AN MRI ON (B)(6) 2017 THAT SHOWED LARGE PERI-IMPLANT FLUID COLLECTION, WHICH WAS COMPRESSING THE IMPLANT. ASPIRATION AND TESTING OF FLUID FOR MALIGNANCY WAS RECOMMENDED AS PATIENT PRESENTED WITH LATE ONSET SEROMA. THE LEFT IMPLANT SHOWED POSSIBILITY OF INTRACAPSULAR RUPTURE. THE PATIENT UNDERWENT BILATERAL CAPSULECTOMIES, RIGHT BREAST SEROMA ASPIRATION, AND BILATERAL REMOVAL AND REPLACEMENT WITH NEW MENTOR MEMORYGEL BREAST IMPLANT 400CC GEL PROTHESES ON (B)(6) 2018. UPON EXPLANTATION, THE LEFT DEVICE WAS RUPTURED, AND RIGHT IMPLANT WAS REMOVED INTACT. THE SEROMA FLUID WAS TESTED AND CAME BACK CD30 NEGATIVE. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449212 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 1004184 00081317000143

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention