BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SILTEX CONTOUR PROFILE HIGH

    MDR report key: 7327293 · Received March 9, 2018

    Report

    Report Number
    1645337-2018-01386
    Event Type
    Injury
    Date Received
    March 9, 2018
    Date of Event
    January 24, 2018
    Report Date
    February 12, 2018
    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
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    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. THE DEVICE HISTORY RECORD (DHR) 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. CONCOMITANT MEDICAL PRODUCTS: RIGHT BREAST IMPLANT SALINE MENTOR SILTEX CONTOUR PROFILE HIGH 350CC, LOT NUMBER 173970, CATALOG NUMBER 3542712. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    UPON RECEIPT BY MENTOR, THE DEVICE RETURNED WITHOUT FLUID. WHITE MATERIAL WAS OBSERVED WITHIN THE DEVICE AND ON THE SHELL SURFACE. PRODUCT EVALUATION TEAM DISCOVERED A RENT MEASURING APPROXIMATELY 0.6 CM ON THE POSTERIOR ASPECT. MICROSCOPIC EXAMINATION OF THE EDGES OF THE RENT GAVE NO INDICATIONS AS TO CAUSE. NO OTHER ANOMALIES WERE DISCOVERED. THE COMPLAINT WAS CONFIRMED SINCE A DEFLATION WAS FOUND ON THE DEVICE. HOWEVER, AT THIS POINT IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF SUCH DAMAGE. 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 · 1

    ON 03/25/2018, ADDITIONAL INFORMATION INDICATES THAT THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT , LEFT: CATALOG NUMBER 3542713, SERIAL NUMBER (B)(4), RIGHT WITH: CATALOG NUMBER 3542713, SERIAL NUMBER (B)(4). ON 04/19/2018, RECEIVED INFORMATION THAT THE PATIENT HAD CAPSULAR CONTRACTURE BILATERALLY. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) ASIAN-CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH MENTOR SILTEX CONTOUR PROFILE 350CC SALINE BREAST IMPLANTS THAT THE LEFT SIDE DEFLATED AFTER IMPLANTATION. THE ISSUE WAS DIAGNOSED DURING THE PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT HAD THE DEVICE EXPLANTED ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169636 MENTOR SILTEX CONTOUR PROFILE HIGH PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 173970 00081317001911

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention