BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SILTEX ROUND MODERATE PROFILE

    MDR report key: 11667150 · Received April 14, 2021

    Report

    Report Number
    1645337-2021-04026
    Event Type
    Injury
    Date Received
    April 14, 2021
    Date of Event
    December 1, 2020
    Report Date
    March 18, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 19-APR-2021, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT: 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. THE SUSPECT MEDICAL DEVICE IS A MENTOR SILTEX ROUND MODERATE PROFILE 275CC SALINE BREAST PROSTHESIS, CATALOG #3542640, UDI #(B)(4), PMA #P990075. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE HAS BEEN DISCARDED. AS A RESULT, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: LEFT BREAST PROSTHESIS DEFLATION, UNSPECIFIED ILLNESS. (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH AN UNSPECIFIED MENTOR SALINE BREAST PROSTHESIS (LEFT DEVICE) AND A MENTOR SILTEX ROUND MODERATE PROFILE 250CC SALINE BREAST PROSTHESIS WHEN THE LEFT BREAST PROSTHESIS DEFLATED AFTER IMPLANTATION. ADDITIONALLY, THE PATIENT DESIRED REPLACEMENT OF BOTH OF HER BREAST PROSTHESES DUE TO AN UNSPECIFIED ILLNESS. THE PATIENT WAS DIAGNOSED WITH HYPERTHYROIDISM IN 2021. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 350CC SALINE BREAST PROSTHESES ON (B)(6) 2021. THE EXPLANTED DEVICES WERE DISCARDED AFTER SURGERY. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563189 MENTOR SILTEX ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 165665

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention