BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

    MDR report key: 8625945 · Received May 20, 2019

    Report

    Report Number
    1645337-2019-12313
    Event Type
    Injury
    Date Received
    May 20, 2019
    Date of Event
    March 4, 2014
    Report Date
    April 23, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING INFORMATION WAS RECEIVED ON 5/22/2019: THE PATIENT SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING AUTOIMMUNE RESPONSE, GREATLY INCREASED ANTI-DS DNA ANTIBODIES, JOINT PAIN, HAIR LOSS, RASH, SWOLLEN GLANDS, MOUTH SORES, NIGHT SWEATS, AND BREAST PAIN. THE DATE OF EVENT WAS IDENTIFIED AS (B)(6) 2014. THE DEVICES WERE IDENTIFIED AS A SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 275CC, CATALOG NUMBER 3502275, LOT NUMBER 6790736 (R) AND A SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 225CC, CATALOG NUMBER 3502225, LOT NUMBER 6791016 (L). THE FOLLOWING INFORMATION WAS RECEIVED ON 6/3/2019: PATIENT DATE OF BIRTH WAS IDENTIFIED AS (B)(6). PATIENT AGE AT THE TIME OF EVENT WAS IDENTIFIED AS (B)(6). THE DEVICE SERIAL NUMBERS WERE IDENTIFIED AS (B)(4). PATIENT RACE WAS IDENTIFIED AS CAUCASIAN. THE PROCEDURE TYPE WAS IDENTIFIED AS A BREAST AUGMENTATION PRIMARY PROCEDURE. ADDITIONAL SYMPTOMS WERE REPORTED INCLUDING FATIGUE AND BRAIN FOG. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THIS REPORT SHALL BE FOR THE RIGHT SIDE. 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. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: DEFECTIVE DEVICE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE WITH UNSPECIFIED MENTOR SALINE BREAST IMPLANTS AND EXPERIENCED A PROBLEM WITH THE IMPLANTS. NO OTHER INFORMATION WAS REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT IS FOR THE FIRST OF TWO DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418428 MENTOR SMOOTH ROUND MODERATE PLUS PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 6790736

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention