BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SILTEX ROUND MODERATE PROFILE

    MDR report key: 10079095 · Received May 21, 2020

    Report

    Report Number
    1645337-2020-06460
    Event Type
    Injury
    Date Received
    May 21, 2020
    Date of Event
    June 7, 2002
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001829
    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

    A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 201260, AND NO NON-CONFORMANCE'S 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 IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: DEFLATION. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A MENTOR SILTEX ROUND MODERATE PROFILE 425CC SALINE PROSTHESIS EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. AS A RESULT, DEVICE REPLACEMENT WAS PERFORMED (B)(6) 2002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543731 MENTOR SILTEX ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 3542670 201260 00081317001829

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention