BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 7611947 · Received June 18, 2018

    Report

    Report Number
    1645337-2018-03702
    Event Type
    Injury
    Date Received
    June 18, 2018
    Date of Event
    February 7, 2018
    Report Date
    June 13, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001256
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CORRECT REPLACEMENT DEVICE SERIAL NUMBER FOR THE LEFT DEVICE IS (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    ON 6/28/2018, THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    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 DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: LEFT MENTOR SMOOTH ROUND MODERATE PROFILE 325CC SALINE BREAST IMPLANT, CATALOG NUMBER 3501650, LOT NUMBER 111717. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH MENTOR SMOOTH ROUND MODERATE PROFILE 325CC SALINE BREAST IMPLANTS WHICH THE LEFT DEFLATED AND THERE WAS BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III AFTER IMPLANTATION. THE ISSUE WAS CONFIRMED BY THE DOCTOR ON (B)(6) 2018. THE LEFT IMPLANT WAS NOTED DEFLATED AND THE CAPSULED WAS NOTED WITH SIGNIFICANT THICKENING AND THERE WAS A TIGHTENING OF THE BREAST LUMEN. THE RIGHT IMPLANT WAS INTACT WITH SIGNIFICANT CAPSULAR THICKENING AS WELL. THE ORIGIN OF DEFLATION OF THE LEFT IMPLANT IS NOT KNOWN, AND THE PATIENT ESTIMATES IT HAS BEEN BROKEN FOR APPROXIMATELY THREE YEARS. THE RIGHT IMPLANT WAS REPLACED WITH MENTOR SMOOTH ROUND MODERATE SALINE CATALOG NUMBER 3501650 SERIAL NUMBER (B)(4). LEFT IMPLANT WAS REPLACED WITH THE SAME STYLE, CATALOG NUMBER 3501650 SERIAL NUMBER (B)(4). THE PATIENT WAS NEVER HOSPITALIZED RELATED TO THIS CASE. SHE IS RECOVERING WITHOUT COMPLICATIONS. THIS REPORT IS FOR THE RIGHT IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451790 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 118096 00081317001256

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention