BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

    MDR report key: 8579814 · Received May 3, 2019

    Report

    Report Number
    1645337-2019-11064
    Event Type
    Injury
    Date Received
    May 3, 2019
    Date of Event
    December 24, 2011
    Report Date
    April 17, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001478
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 5/3/19, A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 5982485, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 8/29/2019, ANOTHER COMPLAINT WAS IDENTIFIED AS A DUPLICATE WITH MANUFACTURER¿S REPORT NUMBER 1645337-2019-11061 AND 1645337-2019-11065. THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2019. THE PATIENT¿S SEX WAS A FEMALE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    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. 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 REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION:N/A. NOTE: THE PATIENT'S EMAIL ADDRESS IS (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA MEDWATCH FORM MW5085173 THAT A (B)(6)-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST IMPLANT SURGERY PROCEDURE WITH SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 500CC AND EXPERIENCED BREAST IMPLANT DEFLATION. IT WAS ALSO REPORTED THAT THE PATIENT DEVELOPED AUTOIMMUNE DISORDER (PATIENT REPORTED ¿AUTOIMMUNE DISEASE, CONNECTION TISSUE DISEASE. (IN THE PROCESS WITH RHEUMATOLOGIST TO KNOW WHAT TYPE OF AUTOIMMUNE I HAVE)¿ AND OTHER SYSTEMIC SYMPTOMS). NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THE SEVERITY LEVEL FOR THIS COMPLAINT WAS DETERMINED AS A S4 THIS ADVERSE EVENT IS CONSIDERED AS SERIOUS AND REPORTABLE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH IS FOR THE LEFT BREAST IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372669 MENTOR SMOOTH ROUND MODERATE PLUS PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5982485 00081317001478

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization| S