BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 8362483 · Received February 22, 2019

    Report

    Report Number
    1645337-2019-08790
    Event Type
    Injury
    Date Received
    February 22, 2019
    Date of Event
    November 17, 2018
    Report Date
    January 31, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001256
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 3/22/2019, MENTOR RECEIVED ADDITIONAL INFORMATION REGARDING THIS EVENT: PATIENT AGE WAS IDENTIFIED AS 58, PATIENT RACE WAS IDENTIFIED AS CAUCASIAN, DATE OF EVENT WAS IDENTIFIED AS (B)(6) 2018, PROCEDURE TYPE WAS IDENTIFIED AS BREAST AUGMENTATION REVISION AND DEVICE SERIAL NUMBER WAS IDENTIFIED AS (B)(4). 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 (MRE) WAS REVIEWED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE WITH A SALINE MENTOR SMOOTH ROUND MODERATE PROFILE 325CC BREAST IMPLANT AND EXPERIENCED DEFLATION ON THE RIGHT SIDE. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANTS 375CC, CATALOG NUMBER 3503751BC, SERIAL NUMBER (B)(4), LOT NUMBER 7595337 (R) AND SERIAL NUMBER (B)(4), LOT NUMBER 6831004 (L) ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156109 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 6713116 00081317001256

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention