BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SILTEX ROUND MODERATE PROFILE

    MDR report key: 8376380 · Received February 27, 2019

    Report

    Report Number
    1645337-2019-08922
    Event Type
    Injury
    Date Received
    February 27, 2019
    Date of Event
    December 1, 2018
    Report Date
    February 5, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001805
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 232548, 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) CAUCASIAN FEMALE UNDERWENT BREAST AUGMENTATION WITH A MENTOR SILTEX ROUND MODERATE PROFILE 350CC SALINE PROSTHESIS AND EXPERIENCED DEFLATION POST PROCEDURE. LEFT SIDED DEFLATION WAS DIAGNOSED BY A PHYSICIAN POST PROCEDURE. ADDITIONALLY, THE PHYSICIAN SUSPECTED BILATERAL CAPSULAR CONTRACTURE (BAKER'S GRADE UNKNOWN). AS A RESULT, THE DEVICES WERE EXPLANTED ON (B)(6) 2019. MENTOR REPORTED THE LEFT SIDED DEFLATION INITIALLY UNDER 1645337-2019-08370 ON (B)(6) 2019. ON (B)(4) 2019 MENTOR BECAME AWARE OF THE PRESENCE OF BILATERAL CAPSULAR CONTRACTURE. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166709 MENTOR SILTEX ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 232548 00081317001805

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention