BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND HIGH PROFILE

    MDR report key: 7806954 · Received August 22, 2018

    Report

    Report Number
    1645337-2018-05121
    Event Type
    Injury
    Date Received
    August 22, 2018
    Date of Event
    July 19, 2018
    Report Date
    July 26, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001652
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: 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 TWO RENTS. RENT A MEASURING APPROXIMATELY 0.8 CM. MICROSCOPIC EXAMINATION OF THE EDGES OF THE RENT A REVEALED PARALLEL STRIATIONS; AND RENT B MEASURING APPROXIMATELY < 0.1 CM WITHIN A CREASE LOCATED BOTH ON THE POSTERIOR ASPECT. NO OTHER ANOMALIES WERE DISCOVERED. THE COMPLAINT WAS CONFIRMED SINCE A RUPTURE WAS FOUND IN THE DEVICE. MICROSCOPIC EXAMINATION REVEALED PARALLEL STRIATIONS. THIS TYPE OF STRIATIONS IS MORE CONCLUSIVE TO SHARP INSTRUMENT DAMAGE RATHER THAN SHELL FAILURE DUE TO WEAR. ALL THE IMPLANTS ARE 100% INSPECTED BEFORE LEAVING THE FACILITY. 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

    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 PRODUCTS: RIGHT MENTOR SMOOTH ROUND HIGH PROFILE 380CC SALINE BREAST IMPLANT, CATALOG NUMBER 3503380, LOT NUMBER 5921304, SERIAL NUMBER (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) HISPANIC FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH MENTOR SMOOTH ROUND HIGH PROFILE 380CC SALINE BREAST IMPLANTS WHICH THE LEFT SIDE DEFLATED AFTER IMPLANTATION. AS A RESULT, PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT AS FOLLOW: LEFT REPLACED WITH CATALOG NUMBER 3504501BC. SERIAL NUMBER (B)(4), AND RIGHT REPLACED WITH CATALOG NUMBER 3504501BC, SERIAL NUMBER (B)(4) ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646171 MENTOR SMOOTH ROUND HIGH PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5921304 00081317001652

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention