BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEMORYGEL BREAST IMPLANT

    MDR report key: 8729299 · Received June 24, 2019

    Report

    Report Number
    1645337-2019-14175
    Event Type
    Injury
    Date Received
    June 24, 2019
    Date of Event
    May 28, 2019
    Report Date
    May 28, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000297
    PMA / PMN Number
    P030053
    Adverse Event
    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, 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 PRODUCTS: MENTOR MEMORYGEL BREAST IMPLANT 325CC, CATALOG #: 3503251BC, SERIAL #: (B)(4), LOT # 6993425. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6)-YEAR-OLD HISPANIC FEMALE UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A MENTOR MEMORYGEL BREAST IMPLANT 325CC AND EXPERIENCED BAKER GRADE III CAPSULAR CONTRACTION ON THE LEFT SIDE POST-OPERATIONAL. 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
    520568 MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 6993425 00081317000297

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other