BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 8908059 · Received August 19, 2019

    Report

    Report Number
    1645337-2019-17433
    Event Type
    Injury
    Date Received
    August 19, 2019
    Report Date
    July 23, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000303
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 (MRE) WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 6921355, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 6901424, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. MANUFACTURING DATE: 2015-02-02. STERILIZATION EXPIRATION DATE: 2020-02-02. 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 WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 350CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED SUSPECTED RUPTURE POST PROCEDURE. THE BREAST IMPLANT WAS DESCRIBED AS FALLING OUT AND COULD BE SEEN AT THE CREASE. THE PATIENT SAW A PHYSICIAN WHO SUSPECTED RUPTURE BUT STATED THEY COULD NOT CONFIRM RUPTURE UNTIL THE REPLACEMENT SURGERY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. ONLY ONE RUPTURE WAS NOTED, HOWEVER, MENTOR WAS UNABLE TO CONFIRM IF SERIAL NUMBER (B)(4) WAS THE DEVICE WITH THE RUPTURE ISSUE. THE INFORMATION FOR SERIAL NUMBER (B)(4) IS BEING PLACED IN SECTION D. HOWEVER MENTOR WILL PROVIDE INFORMATION FOR BOTH SERIAL NUMBERS IN THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702512 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 6921355 00081317000303

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other