BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 12170754 · Received July 14, 2021

    Report

    Report Number
    1645337-2021-07973
    Event Type
    Injury
    Date Received
    July 14, 2021
    Date of Event
    June 22, 2021
    Report Date
    June 22, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000495
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    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 WAS PERFORMED FOR THE FINISHED DEVICE 6920795 NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. MANUFACTURING DATE: APR/07/2015. EXPIRATION DATE: APR/03/2020. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 6857292 NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. MANUFACTURING DATE: AUG/26/2014. EXPIRATION DATE: AUG/31/2019. 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 (B)(6) YEAR-OLD FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION SURGERY WITH A 375CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A RUPTURE ON AN UNSPECIFIED SIDE POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. TWO LOT NUMBERS WERE PROVIDED. IT IS UNCLEAR AS TO WHICH SIDE IS IMPACTED. THIS REPORT HAS BEEN DEFAULTED TO LOT NUMBER 6920795.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1067341 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3503754BC 6920795 00081317000495

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other