BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SILTEX ROUND MODERATE PROFILE

    MDR report key: 7980044 · Received October 18, 2018

    Report

    Report Number
    1645337-2018-06256
    Event Type
    Injury
    Date Received
    October 18, 2018
    Date of Event
    June 7, 2018
    Report Date
    September 26, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001751
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED AT MENTOR WITHOUT FLUID. WHITE MATERIAL WAS OBSERVED WITHIN THE DEVICE AND ON THE SHELL SURFACE. UPON VISUAL EXAMINATION, THE DEVICE APPEARS INTACT. NO OTHER ANOMALIES WERE DISCOVERED. A ROOT CAUSE FAILURE ANALYSIS WILL NOT BE CONDUCTED SINCE THE INVESTIGATION COULD NOT CONFIRM THAT AN ACTUAL FAILURE OF THE DEVICE TO CONFORM TO EXPECTED PERFORMANCE HAD OCCURRED. THE DEVICE HISTORY RECORD (DHR) OF LOT NUMBER 223747 WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR 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. THE 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. SOME BREAST PTOSIS IS A NORMAL COMPONENT OF THE MATURE BREAST. PTOSIS IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET. (B)(4).

    Additional Manufacturer Narrative · 1

    THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 10/1/2018. THE ANALYSIS HAS BEGUN, BUT IS NOT COMPLETE AT THIS TIME. WHEN THE INVESTIGATION AND ANALYSIS HAVE BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. A DEVICE HISTORY RECORD REVIEW 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) CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH MENTOR SILTEX ROUND MODERATE PROFILE 225CC SALINE PROSTHESES. DEFLATION AND PAIN AND ON THE LEFT BREAST PROSTHESIS WAS DIAGNOSED POST PROCEDURE THROUGH A PHYSICAL EXAMINATION. CAPSULAR CONTRACTURE BAKER GRADE II WAS DIAGNOSED IN THE RIGHT BREAST PROSTHESIS. BILATERAL PTOSIS WAS ALSO INDICATED. AS A RESULT, THE PATIENT UNDERWENT REMOVAL WITHOUT REPLACEMENT OF THE BREAST PROSTHESES ON (B)(6) 2018. BILATERAL CAPSULECTOMIES AND BILATERAL SUPERIOR-MEDIAL WISE PATTERN MASTOPEXIES WERE PERFORMED. THE PATIENT TOLERATED THE PROCEDURE WELL. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS. SEE MANUFACTURER REPORT NUMBER 1645337-2018-05626 FOR THE CONTRALATERAL PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818270 MENTOR SILTEX ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 223747 00081317001751

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention