BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

    MDR report key: 14434199 · Received May 19, 2022

    Report

    Report Number
    1645337-2022-05777
    Event Type
    Injury
    Date Received
    May 19, 2022
    Date of Event
    February 13, 2022
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001386
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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, 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. ACCORDING TO THE REVISION CARRIED OUT ON APR/28/2022 FOR LOT NUMBER 9550674. NON-CONFORMANCES WERE FOUND WITH NUMBER NR-0166746 RELATED TO DEVICE MALFUNCTION. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: DEFLATION . FDA CORRECTION/ REMOVAL REPORTING NO. 3005423519-10/12/2021-00 . MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION SURGERY WITH TWO 275CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANTS EXPERIENCED BILATERAL DEFLATION POST PROCEDURE. AS A RESULT, PATIENT HAS A PLANNED EXPLANTATION ON (B)(6) 2022. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393340 MENTOR SMOOTH ROUND MODERATE PLUS PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 3502275 9550674 00081317001386

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention