BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

    MDR report key: 8429700 · Received March 18, 2019

    Report

    Report Number
    1645337-2019-09408
    Event Type
    Injury
    Date Received
    March 18, 2019
    Date of Event
    February 1, 2019
    Report Date
    February 25, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001416
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT BY MENTOR, THE DEVICE RETURNED WITHOUT FLUID. WHITE MATERIAL WAS OBSERVED WITHIN THE DEVICE. NO FOREIGN MATERIAL WAS OBSERVED ON THE SHELL SURFACE. MENTOR PRODUCT ANALYSIS LAB DISCOVERED A RENT MEASURING APPROXIMATELY 0.1 CM WITHIN A CREASE ON THE ANTERIOR ASPECT. NO OTHER ANOMALIES WERE DISCOVERED. THE COMPLAINT WAS CONFIRMED SINCE A RUPTURE WAS FOUND ON THE DEVICE. HOWEVER, AT THIS POINT IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF SUCH DAMAGE OR THE ETIOLOGY OF THE WHITE MATERIAL FOUND ON THE DEVICE. A MANUFACTURING RECORD EVALUATION (MRE) OF LOT NUMBER 6407105 WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH MANUFACTURING. CAPSULAR CONTRACTURE IS THE RESULT OF THE BODY¿S INDIVIDUAL PHYSIOLOGICAL RESPONSE TO THE IMPLANTATION OF A FOREIGN OBJECT IN SOFT TISSUE. BREAST IMPLANTS ARE NOT CONSIDERED LIFETIME DEVICES AND DEFLATION IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR PRODUCT INSERT DATA SHEET. MENTOR PRODUCT ANALYSIS LAB CONCLUDED THE REPORTED COMPLAINT OF CAPSULAR CONTRACTURE IN THE PATIENT¿S BREAST WAS THE RESULT OF THE BODY¿S INDIVIDUAL PHYSIOLOGICAL RESPONSE TO THE IMPLANTATION OF A FOREIGN OBJECT IN SOFT TISSUE. CAPSULAR CONTRACTURE IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED ON 3/21/2019 INDICATED THE PATIENT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. THE LEFT SIDE IMPLANT WAS CONFIRMED TO BE DEFLATED, HOWEVER THE RIGHT SIDE WAS FOUND TO BE INTACT. THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANTS 400CC, CATALOG NUMBER 3504004BC, LOT NUMBER 7672439, SERIAL NUMBER (B)(4) (R) AND (B)(4) (L). ON 3/26/2019, THE MENTOR FAILURE ANALYSIS LAB 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. ON 4/15/2019, IT WAS NOTICED THAT THE FOLLOWING INFORMATION WAS MISTAKENLY OMITTED FROM (EVENT DESCRIPTION) IN THE INITIAL REPORT 1645337-2019-09408 SUBMITTED ON 3/18/2019: "THE PATIENT UNDERWENT BILATERAL REMOVAL ON (B)(6) 2019". 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. A MANUFACTURING RECORD EVALUATION (MRE) WAS REVIEWED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) ASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 350CC BREAST IMPLANTS AND EXPERIENCED BILATERAL DEFLATION. PATIENT STATED THE DEFLATION MAY HAVE BEEN CAUSED BY THE MAMMOGRAM. THIS REPORT IS FOR THE LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223649 MENTOR SMOOTH ROUND MODERATE PLUS PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 6407105 00081317001416

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention