BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 8437418 · Received March 20, 2019

    Report

    Report Number
    1645337-2019-09513
    Event Type
    Injury
    Date Received
    March 20, 2019
    Date of Event
    November 1, 2018
    Report Date
    February 21, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000679
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. IT IS UNKNOWN AT THIS TIME IF THE DEVICE WILL BE MADE AVAILABLE FOR RETURN. AS A RESULT, 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 FOR THE FINISHED DEVICE NUMBER 210561, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE UNDERWENT BREAST AUGMENTATION REVISION WITH A 300CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED RIGHT SIDED RUPTURE CONFIRMED BY TOMOGRAPHY POST PROCEDURE. ON 3/4/2018 MENTOR RECEIVED ADDITIONAL INFORMATION THAT THE PATIENT HAD BILATERAL IMPLANT SITE CALCIFICATIONS AS WELL. AN ADDITIONAL IMPACTED PRODUCT WAS CREATED FOR THE LEFT PROSTHESIS UNDER 1645337-2019-09512 USING (B)(4) 2019 AS THE AWARENESS DATE TO CAPTURE THIS EVENT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230059 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 210561 00081317000679

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other