BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SILTEX CONTOUR PROFILE HIGH

    MDR report key: 8471918 · Received April 1, 2019

    Report

    Report Number
    1645337-2019-09871
    Event Type
    Injury
    Date Received
    April 1, 2019
    Date of Event
    January 17, 2019
    Report Date
    March 5, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001911
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 5/2/2019, A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE COMPLAINT DEVICE. AS A RESULT, THE MANUFACTURING DATE AND EXPIRATION DATE FIELDS HAVE BEEN UPDATED. ON 5/2/2019, THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE INVESTIGATION SUMMARY: UPON RECEIPT BY MENTOR, THE DEVICE RETURNED WITHOUT FLUID. YELLOW MATERIAL WAS OBSERVED WITHIN THE DEVICE. ORANGE MATERIAL WAS OBSERVED ON THE SHELL SURFACE. UPON INITIAL INSPECTION THE DEVICE APPEARS INTACT. NO OTHER ANOMALIES WERE DISCOVERED. BECAUSE THE AUTHORIZATION FOR RETURN AND EXAMINATION OF MEDICAL DEVICE FORM WAS NOT SIGNED AND/OR RETURNED TO MENTOR, MENTOR PRODUCT ANALYSIS LAB WAS PRECLUDED FROM FURTHER EVALUATING THE DEVICE. COMPLAINT WAS NOT CONFIRMED. A MANUFACTURING RECORD EVALUATION (MRE) OF LOT NUMBER 151022 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. 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 4/3/2019, 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. 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 DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: 350CC MENTOR SILTEX CONTOUR PROFILE HIGH SALINE CATALOG: 3542712 LOT: 151022. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 350CC MENTOR SILTEX CONTOUR PROFILE HIGH SALINE BREAST PROSTHESES, EXPERIENCED LEFT SIDE DEFLATION POST-OPERATIVELY. DEFLATION WAS DIAGNOSED PER VISUAL EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH A 550CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE ON THE LEFT AND A 600CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE ON THE RIGHT ON (B)(6)2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261979 MENTOR SILTEX CONTOUR PROFILE HIGH PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 151022 00081317001911

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention