BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 8352225 · Received February 19, 2019

    Report

    Report Number
    1645337-2019-08681
    Event Type
    Injury
    Date Received
    February 19, 2019
    Date of Event
    October 1, 2018
    Report Date
    January 28, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001287
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2019, IT WAS REPORTED TO MENTOR THAT A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 250382, AND NO NON-CONFORMANCE'S RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. 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 MANUFACTURING RECORD EVALUATION REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: A SALINE MENTOR SMOOTH ROUND MODERATE PROFILE 425CC, CATALOG NUMBER 3501670, LOT NUMBER 250382, SERIAL NUMBER (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) AFRICAN AMERICAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A SALINE MENTOR SMOOTH ROUND MODERATE PROFILE 425CC AND EXPERIENCED CAPSULAR CONTRACTURE ON THE LEFT BREAST IMPLANT. AS A RESULT, THE PATIENT WILL UNDERGO EXPLANTATION AND REPLACEMENT WITH SILICONE BREAST IMPLANTS ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144920 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 250382 00081317001287

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other| R SEE H10.