BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 16234375 · Received January 24, 2023

    Report

    Report Number
    1645337-2023-00732
    Event Type
    Injury
    Date Received
    January 24, 2023
    Date of Event
    February 17, 2017
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000273
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON JANUARY 31, 2023, MENTOR BECAME AWARE THAT MANUFACTURER REPORT NUMBER 1645337-2023-00732 IS A DUPLICATE REPORT OF MANUFACTURER REPORT NUMBER 1645337-2019-15329. ANY ADDITIONAL INFORMATION WILL BE REPORTED UNDER THE MANUFACTURER'S REPORT NUMBER 1645337-2019-15329. CORRESPONDING FIELDS HAVE BEEN UPDATED ON THIS FORM. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    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. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: LEFT CAPSULAR CONTRACTURE; BAKER GRADE III. MENTOR IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH MENTOR HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, MENTOR, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MENTOR, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    THIS EVENT IS ASSOCIATED WITH THE GLOW CLINICAL TRIAL; SUBJECT ID: 940-014. IT WAS REPORTED THAT A 25-YEAR-OLD FEMALE PATIENT UNDERWENT REVISION-AUGMENTATION SURGERY WITH 275CC MENTOR MEMORYGEL BREAST IMPLANT ON THE RIGHT SIDE, AND UNKNOWN SIZE UNKNOWN GEL IMPLANT ON THE LEFT AND EXPERIENCED RIGHT SIDE CAPSULAR CONTRACTURE; BAKER GRADE IV POSTOPERATIVELY. AS A RESULT, THE RIGHT SIDE DEVICE WAS EXPLANTED ON (B)(6) 2018. ON JANUARY 3, 2023, MENTOR BECAME AWARE THAT PATIENT ALSO EXPERIENCED LEFT SIDE CAPSULAR CONTRACTURE; BAKER GRADE III, AND THE DEVICE WAS EXPLANTED ON (B)(6) 2019. THIS SUPPLEMENTAL MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594787 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3502751BC 7360235 00081317000273

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Female Required Intervention