BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

    MDR report key: 8106512 · Received November 27, 2018

    Report

    Report Number
    1645337-2018-07044
    Event Type
    Injury
    Date Received
    November 27, 2018
    Date of Event
    October 1, 2018
    Report Date
    November 27, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001478
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 6/27/2019, DURING EVALUATION OF THE SAMPLE IT WAS OBSERVED TO BE INTACT. NO ADDITIONAL ANOMALIES WERE OBSERVED. BASED ON THE FACTS OF THE CASE, IS UNRELATED TO THE BREAST IMPLANT AND RELATED TO THE PATIENT CONDITION. IMPLANT DISPLACEMENT/MIGRATION MAY OCCUR FROM IMPROPER IMPLANT SIZING AND/OR PLACEMENT, I.E., WHEN THE IMPLANT IS TOO LARGE OR THE POCKET TOO SMALL OR WHEN THERE HAS BEEN INADEQUATE PREOPERATIVE ASSESSMENT OF STRESSES CAUSING MOVEMENT OF THE PROSTHESIS. THE MANUFACTURING RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT. NO FURTHER INVESTIGATION WILL BE CONDUCTED ON THIS COMPLAINT DUE TO EXTERNAL CAUSE. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. THIS REPORT IS NOT INTENDED TO DENY THAT YOU EXPERIENCED A PROBLEM WITH THE DEVICE. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 5910447, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    THE MENTOR FAILURE ANALYSIS LAB HAS RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN, BUT IS NOT COMPLETE AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. A DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: A SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 500CC, CATALOG NUMBER 3502500, SERIAL NUMBER (B)(4), LOT NUMBER 5915569. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 500CC BREAST IMPLANTS AND EXPERIENCED DEFLATION AND CAPSULAR CONTRACTURE ON THE RIGHT BREAST IMPLANT. THE DEFLATION WAS CONFIRMED BY THE HEALTHCARE PROFESSIONAL. THE PATIENT EXPERIENCED DEVICE MIGRATION ON THE LEFT BREAST IMPLANT. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH SALINE MENTOR SMOOTH ROUND HIGH PROFILE 500CC, CATALOG NUMBER 3503500, SERIAL NUMBER (B)(4), LOT NUMBER 7595315 ON THE LEFT BREAST IMPLANT AND WITH SALINE MENTOR SMOOTH ROUND HIGH PROFILE 500CC , CATALOG NUMBER 3503500, SERIAL NUMBER (B)(4), LOT NUMBER 7595315 ON THE RIGHT BREAST IMPLANT ON (B)(6) 2018. THE PATIENT WAS IN A STABLE CONDITION AFTER THE SURGERY. THE PATIENT TOLERATED THE PROCEDURE WELL. THIS MEDWATCH IS FOR THE LEFT BREAST IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    944505 MENTOR SMOOTH ROUND MODERATE PLUS PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5910447 00081317001478

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other| R