BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 9547035 · Received January 3, 2020

    Report

    Report Number
    1645337-2020-00193
    Event Type
    Injury
    Date Received
    January 3, 2020
    Report Date
    December 9, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000297
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 5862683 NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED WITH THE RETURNED DEVICE ON (B)(6) 2020. INITIALLY MENTOR RECEIVED INFORMATION THAT ONE OF THE TWO DEVICES WAS RUPTURED. IT WAS ASSUMED THAT THE DEVICE ASSOCIATED WITH THE CAPSULAR CONTRACTURE DEVICE WAS ALSO THE ONE THAT HAD RUPTURED, AS RUPTURE CAN BE CAUSED BY CAPSULAR CONTRACTURE. HOWEVER THE DEVICE RECEIVED, APPEARED RUPTURED, AND HAD THE LOT NUMBER OF THE DEVICE THAT WAS ORIGINALLY THOUGHT TO BE CONCOMITANT. THEREFORE THE RUPTURE IS BEING REPORTED UNDER 1645337-2020-01121. THIS PRODUCT IS BEING TREATED SOLELY AS AN INCIDENCE OF CAPSULAR CONTRACTURE. H6 HAS BEEN UPDATED. 1. IS PRODUCT PROBLEM- UNCHECK REASON FOR DEVICE EXPLANT AND/OR REOPERATION: CAPSULAR CONTRACTURE MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    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 IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: CAPSULAR CONTRACTURE. CONCOMITANT PRODUCTS: 450CC MENTOR MEMORYGEL BREAST IMPLANT, CATALOG # 3504504BC, SERIAL # (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD PATIENT WITH A HISTORY OF BREAST CANCER WHO UNDERWENT BREAST RECONSTRUCTION REVISION WITH A 325CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED LEFT SIDED BAKER GRADE IV CAPSULAR CONTRACTURE AND RUPTURE POST PROCEDURE. THIS WAS ACCOMPANIED BY PAIN. THE PATIENT UNDERWENT BILATERAL IMPLANT EXCHANGE WITH BILATERAL CAPSULECTOMIES AS A RESULT. THE LEFT REPLACEMENT WAS A 300CC MENTOR MEMORYGEL BREAST IMPLANT AND THE RIGHT REPLACEMENT WAS A 400CC MENTOR MEMORYGEL BREAST IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7411 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3503251BC 5862683 00081317000297

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention