BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR PROFILE GEL

    MDR report key: 7680267 · Received July 11, 2018

    Report

    Report Number
    1645337-2018-04210
    Event Type
    Injury
    Date Received
    July 11, 2018
    Date of Event
    June 14, 2018
    Report Date
    June 15, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 6/22/2018. THE ANALYSIS HAS BEGUN, BUT IS NOT COMPLETE AT THIS TIME. WHEN THE INVESTIGATION AND ANALYSIS HAVE BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. SINCE NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD (DHR) REVIEW COULD BE PERFORMED. CONCOMITANT PRODUCTS: RIGHT CONTOUR PROFILE GEL PROSTHESIS, CATALOG: 354-1358G, SERIAL NUMBER: (B)(4), LOT: 253033. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: THE DEVICE WAS RETURNED AT MENTOR CONTAINING A CLEAR GEL. NO FOREIGN MATERIAL WAS OBSERVED WITHIN THE DEVICE OR ON THE SHELL SURFACE. UPON INSPECTION, THE DEVICE APPEARED INTACT AND NO ANOMALIES WERE OBSERVED. MENTOR PERFORMS 100% INSPECTION AND TESTING OF ALL DEVICES PRIOR TO RELEASE. A ROOT CAUSE FAILURE ANALYSIS WILL NOT BE CONDUCTED SINCE THE INVESTIGATION OF THE REPORTED FAILURE COULD NOT CONFIRM THAT AN ACTUAL FAILURE OF THE DEVICE TO CONFORM TO EXPECTED PERFORMANCE HAD OCCURRED. IMPLANT DISPLACEMENT/MIGRATION MAY OCCUR FROM IMPROPER IMPLANT SIZING AND/OR PLACEMENT, I.E., WHEN THE IMPLANT IS TOO LARGE OR THE POCKET TOO SMALL OR WHEN THERE HAS BEEN INADEQUATE PREOPERATIVE ASSESSMENT OF STRESSES CAUSING MOVEMENT OF THE PROSTHESIS. IMPLANT DISPLACEMENT/MIGRATION IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION REVISION WITH MENTOR CONTOUR PROFILE GEL PROSTHESES ON (B)(6) 2003 DEVELOPED RIGHT IMPLANT ROTATION. THE PATIENT HAD CONCERNS REGARDING ALCL AND WANTED BETTER RESULT (SOFTER BREAST AND BETTER DEFINITION OF THE INFRAMAMMARY FOLD). THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT OF IMPLANTS WITH MENTOR MEMORYGEL BREAST IMPLANT 400CC GEL PROSTHESES ON (B)(6) 2018. BOTH DEVICES WERE INTACT PER PRODUCT INVESTIGATION. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521909 CONTOUR PROFILE GEL UNK FTR MENTOR TEXAS

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention