BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND HIGH PROFILE

    MDR report key: 7629632 · Received June 22, 2018

    Report

    Report Number
    1645337-2018-03846
    Event Type
    Injury
    Date Received
    June 22, 2018
    Date of Event
    November 1, 2017
    Report Date
    June 4, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001706
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON FEBRUARY 5, 2024, MENTOR RECEIVED ADDITIONAL INFORMATION REGARDING AN UPDATE TO THE PATIENT'S EXPERIENCE. THE PATIENT WAS HAVING HORRIBLE PAIN ON THE RIGHT BREAST AND THE IMPLANT WAS MOVING. THE PATIENT WENT TO AN EMERGENCY ROOM AND WAS INFORMED THAT THE IMPLANT WAS LEAKING, PER CT SCAN AND X-RAY.

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN 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. 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. CONCOMITANT PRODUCTS: SALINE MENTOR SMOOTH ROUND HIGH PROFILE 630 CC, SERIAL NUMBER: (B)(4), LOT NUMBER: 7010260, CATALOG NUMBER: 3503630. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH SALINE MENTOR SMOOTH ROUND HIGH PROFILE 630 CC ON (B)(6) 2016 IS EXPERIENCING RIGHT BREAST PAIN AND POSSIBLE DEVICE MIGRATION / DEFLATION. THE PATIENT REPORTS THERE IS A BUBBLE NEAR HER NIPPLE THAT SHE CAN PUSH DOWN AND IT'LL APPEAR SOMEWHERE ELSE. A PHYSICIAN BELIEVES IT IS RIPPLING. THE PATIENT HAS NOT UNDERGONE ANY SURGICAL INTERVENTION AS OF YET. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471806 MENTOR SMOOTH ROUND HIGH PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 7282074 00081317001706

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Other