BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 8677215 · Received June 6, 2019

    Report

    Report Number
    1645337-2019-13429
    Event Type
    Injury
    Date Received
    June 6, 2019
    Date of Event
    January 1, 2016
    Report Date
    May 7, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000303
    PMA / PMN Number
    P030053
    Adverse Event
    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, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: N/A. CONCOMITANT MEDICAL PRODUCTS: 350CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3503501BC LOT: 5771597 SN: (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6)-YEAR OLD FEMALE (B)(6) FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 350CC MENTOR MEMORYGEL BREAST IMPLANTS, EXPERIENCED THE FOLLOWING ON THE RIGHT BREAST POST-OPERATIVELY: HARD AT THE TOP, SOMETIMES SWELLS, HAVE PRESSURE, ITCHING AT TIMES, AND APPEARS TO BE DISTORTED. 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
    466723 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 5771597 00081317000303

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other