BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SILTEX ROUND MODERATE PROFILE

    MDR report key: 9900500 · Received March 30, 2020

    Report

    Report Number
    1645337-2020-05006
    Event Type
    Injury
    Date Received
    March 30, 2020
    Date of Event
    February 27, 2020
    Report Date
    March 6, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317003687
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 13-JUL-2020, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT: - THE INITIAL INFORMATION RECEIVED ABOUT THE IDENTITY OF THE SUSPECT MEDICAL DEVICE IS INCORRECT. IT WAS INITIALLY REPORTED TO MENTOR THAT THE SUSPECT MEDICAL DEVICE IS A MENTOR CPX 3 BREAST TISSUE EXPANDER WITH SUTURING TABS DEVICE, CATALOG #3547213, LOT #6593393, UDI #(B)(4), 510(K) #K011500. NEW INFORMATION RECEIVED STATES THAT THE SUSPECT MEDICAL DEVICE IS A MENTOR SILTEX ROUND MODERATE PROFILE 375CC SALINE BREAST PROSTHESIS, CATALOG #3542660, LOT #6593398, SERIAL #(B)(6), UDI #(B)(4), PMA #P990075. 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. - DEVICE CODE 1494 ¿OFF-LABEL USE¿ NO LONGER APPLIES TO THIS EVENT. UNLIKE TISSUE EXPANDERS, SALINE BREAST PROSTHESES CAN BE IMPLANTED IN PATIENTS FOR LONGER THAN SIX MONTHS. ON 30-JUL-2020, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT: - THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 325CC SALINE BREAST PROSTHESES ON (B)(6) 2020. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 17-APR-2020, 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. IT IS UNKNOWN AT THIS TIME IF THE DEVICE WILL BE MADE AVAILABLE FOR RETURN. AS A RESULT, 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. 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 BREAST AUGMENTATION PROCEDURE WITH A MENTOR CPX 3 BREAST TISSUE EXPANDER WITH SUTURING TABS 450CC DEVICE THAT DEFLATED AFTER IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT TISSUE EXPANDER WAS REPORTED. THE DEVICE WAS IMPLANTED IN THE PATIENT FOR LONGER THAN 6 MONTHS, WHICH IS AGAINST THE IFU. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364300 MENTOR SILTEX ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 3547213 6593398 00081317003687

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other| R