BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 12119346 · Received July 5, 2021

    Report

    Report Number
    1645337-2021-07518
    Event Type
    Injury
    Date Received
    July 5, 2021
    Report Date
    June 11, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 8/17/2021, IT WAS REPORTED TO MENTOR THAT THE PATIENT SUFFERED FROM RIGHT MALPOSITION AND BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III/IV ON THE RIGHT SIDE AND II ON THE LEFT SIDE. IN ADDITION, THE DATE OF IMPLANTATION WAS (B)(6) 2019. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON JULY 12, 2021, MENTOR BECAME AWARE THAT THE AFFECTED DEVICES WERE LEFT SIDE: MENTOR MEMORYGEL BREAST IMPLANT 450CC, CATALOG NUMBER 3507450BC , SN (B)(6), LOT 5932015 AND RIGHT SIDE CATALOG 3507450BC, SN (B)(6), LOT 5932015. ON 7/27/2021 , A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 5932015 NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING THE 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. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION REVIEW COULD BE PERFORMED. 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 FEMALE PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH UNKNOWN MENTOR BREAST IMPLANTS EXPERIENCED BILATERAL ANISOMASTIA AND BREAST MASS POSTOPERATIVELY. THE PATIENT REPORTED FEELING LUMPS IN THE BREASTS, AND THE BREASTS ARE ALSO DEFORMED. THE PATIENT IS CONCERNED FOR HER HEALTH AND IS CONSIDERING EXPLANTATION; HOWEVER, MENTOR HAS RECEIVED NO INFORMATION REGARDING THE EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT HAS BEEN DEFAULTED TO GEL BREAST IMPLANT DUE TO UNKNOWN TYPE, AND THE COMMON DEVICE NAME AND PROCODE ARE BEING REPORTED FOR SUBMISSION PURPOSES ONLY. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED AS APPLICABLE. THIS MEDWATCH REPORT IS FOR THE SECOND OF TWO IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1012483 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 5932015

    Patients

    Seq Age Sex Outcome Treatment
    1 Other