BEUDAMED
    FDA Adverse Event Injury Summary report: N

    650CC MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 9139678 · Received October 1, 2019

    Report

    Report Number
    1645337-2019-20338
    Event Type
    Injury
    Date Received
    October 1, 2019
    Date of Event
    August 1, 2017
    Report Date
    April 12, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000563
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE REPORT IS BEING SUBMITTED LATE AS A RESULT OF THE EXEMPTION TRANSITION PERIOD FOLLOWING THE REVOCATION OF MENTOR¿S PSR EXEMPTION # E2007003. INVESTIGATION SUMMARY: DURING EVALUATION OF THE SAMPLE A TEAR WAS OBSERVED WITHIN A FOLD OR WRINKLE RUNNING FROM THE ANTERIOR TO THE POSTERIOR ASPECT OF THE IMPLANT, MEASURING APPROXIMATELY 15.5 CM. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 6863808, AND NO NON-CONFORMANCE RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. A FOLD OR WRINKLE RUPTURE IS A KNOWN INHERENT RISK ASSOCIATED WITH THE USE OF MAMMARY PROSTHESES. AS STATED IN THE PRODUCT INSERT DATA SHEET, CREATING WRINKLES OR FOLDS SHOULD BE AVOIDED DURING IMPLANTATION OR OTHER PROCEDURES AS IT CAN RESULT IN RUPTURE IN A LATER TIME. BASED ON THE INFORMATION REPORTED AND THE PRODUCT INVESTIGATION, NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. AS A RESULT, WE ARE CLOSING THIS INVESTIGATION. IF ADDITIONAL INFORMATION IS RECEIVED IN THE FUTURE, WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: RUPTURE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    THIS REPORT CONTAINS THE SUPPLEMENTAL INFORMATION FOR MENTOR PSR REFERENCE NUMBER (B)(4). IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH TWO 650CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED POSTOPERATIVE BILATERAL RUPTURE. LEFT-SIDED RUPTURE WAS CONFIRMED VIA MRI IN (B)(6) 2017. AS A RESULT OF THE LEFT-SIDED RUPTURE, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT ON (B)(6) 2019. THE REPLACEMENT DEVICES ARE NON-MENTOR BREAST IMPLANTS, AND RIGHT-SIDED RUPTURE WAS DISCOVERED DURING THE REVISION SURGERY. THIS REPORT IS FOR THE RIGHT PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    932972 650CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 6863808 00081317000563

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention