BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 8438993 · Received March 20, 2019

    Report

    Report Number
    1645337-2019-09542
    Event Type
    Injury
    Date Received
    March 20, 2019
    Date of Event
    September 15, 2011
    Report Date
    February 19, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2019, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT: - THE PATIENT¿S DATE OF BIRTH IS 05/17/1961. SHE WAS 50 YEARS OLD AT THE TIME OF THE EVENT. - THE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH THE SUSPECT MEDICAL DEVICE. - THE PATIENT WAS DIAGNOSED WITH RHEUMATOID ARTHRITIS IN 2013. - IT WAS INITIALLY REPORTED THAT THE IMPLANTATION DATE IS (B)(6) 2011. NEW INFORMATION STATES THAT THE IMPLANTATION DATE IS (B)(6) 2007. - THE SUSPECT MEDICAL DEVICE IS A MENTOR SMOOTH ROUND MODERATE PROFILE 350CC SALINE BREAST PROSTHESIS, CATALOG #3501655, LOT #5750274, SERIAL #(B)(4) PMA #P990075, UDI #(B)(4). A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 04/15/2019, 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

    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. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION (MRE) COULD BE PERFORMED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT AN UNKNOWN PROCEDURE WITH UNSPECIFIED MENTOR SALINE BREAST PROSTHESES DEVELOPED AUTOIMMUNE ISSUES WHICH RESULTED IN BEING DIAGNOSED WITH LUPUS, INSOMNIA, BRAIN FOG, AND GUT ISSUES. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2018. IT WAS REPORTED THAT THE PATIENT FEELS MUCH BETTER SINCE REMOVING HER BREAST PROSTHESES. THIS MEDWATCH REPORT IS FOR THE LEFT BREAST PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231430 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5750274

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention| S