BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND SPECTRUM

    MDR report key: 8450217 · Received March 25, 2019

    Report

    Report Number
    1645337-2019-09669
    Event Type
    Injury
    Date Received
    March 25, 2019
    Date of Event
    January 26, 2019
    Report Date
    February 27, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317002024
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    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 (MRE) WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 231822, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE UNDERWENT PRIMARY BREAST AUGMENTATION WITH MENTOR SMOOTH ROUND SPECTRUM 475CC SALINE PROSTHESES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE POST PROCEDURE (BAKER¿S GRADE UNKNOWN). AS A RESULT, REPLACEMENT WITH NATRELLE IMPLANTS WAS PERFORMED ON (B)(6) 2019. SEE 1645337-2019-09668 FOR CONTRALATERAL PROSTHESIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241424 MENTOR SMOOTH ROUND SPECTRUM PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 231822 00081317002024

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention