BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 11354862 · Received February 19, 2021

    Report

    Report Number
    1645337-2021-01800
    Event Type
    Injury
    Date Received
    February 19, 2021
    Date of Event
    January 26, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000303
    PMA / PMN Number
    P030053
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A MANUFACTURING RECORD EVALUATION WAS PERFORMED ON MARCH 4, 2021 FOR THE FINISHED DEVICE 6990260 NUMBER, AND NO NON-CONFORMANCE'S WERE IDENTIFIED. MANUFACTURING DATE: OCT/21/2015. EXPIRATION DATE: OCT/21/2020. A MANUFACTURING RECORD EVALUATION WAS PERFORMED ON (B)(6) 2021 FOR THE FINISHED DEVICE 6970650 NUMBER, AND NO NON-CONFORMANCE'S WERE IDENTIFIED. MANUFACTURING DATE: SEP/02/2015. EXPIRATION DATE: SEP/02/2020. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON MAY 6, 2021. THE DEVICE SIDE INITIALLY REPORTED AS UNKNOWN WAS CLARIFIED TO BE RIGHT. THE LOT AND SERIAL NUMBER WERE ABLE TO BE CONFIRMED AS (B)(6), RESPECTIVELY WITH THIS INFORMATION. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    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 IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: N/A. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT WHO HAD A 350CC MENTOR MEMORYGEL BREAST IMPLANT PLACED EXPERIENCED RUPTURE ON AN UNKNOWN SIDE POST PROCEDURE. THE RUPTURE WAS DIAGNOSED THROUGH ULTRASOUND. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. BOTH LOT NUMBERS (B)(4) WERE PROVIDED WITH SERIAL NUMBERS (B)(4) HOWEVER, MENTOR WAS NOT PROVIDED INFORMATION AS TO WHICH LOT/SERIAL NUMBER BELONGS TO THE RUPTURED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244927 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3503501BC 6970650 00081317000303

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Other| R