BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYSHAPE

    MDR report key: 9225492 · Received October 23, 2019

    Report

    Report Number
    1645337-2019-22390
    Event Type
    Injury
    Date Received
    October 23, 2019
    Date of Event
    May 1, 2019
    Report Date
    September 26, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS, 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: DEFLATION, DEVICE MIGRATION CONCOMITANT PRODUCTS: (LEFT) 390CC MENTOR MEMORYSHAPE¿ MH CATALOG: 3341202G LOT: 5924437 SN: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6)-YEAR OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 390CC MENTOR MEMORYSHAPE GEL IMPLANTS, EXPERIENCED A RIGHT BREAST THAT WAS ABNORMALLY SMALLER, MAY HAVE TURNED AND FELT DIFFERENT, "SCRUNCHINESS" ON THE SIDE AND COULD HAVE LEAKED. AS A RESULT, THE PATIENT UNDERWENT IMPLANT EXPLANTATION ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017781 MENTOR MEMORYSHAPE PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 6006752

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention