BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 10097426 · Received May 28, 2020

    Report

    Report Number
    1645337-2020-06601
    Event Type
    Injury
    Date Received
    May 28, 2020
    Date of Event
    February 1, 2020
    Report Date
    May 5, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001270
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED ON JULY 22, 20220 INDICATED THAT THE PATIENT UNDERWENT BILATERAL REPLACEMENTS AS FOLLOW: LEFT REPLACED WITH CAT#: 3505004BC;SN#: (B)(6), AND RIGHT REPLACED WITH CAT#:3505004BC SN#: (B)(6) ON (B)(6) 2020. DATE OF IMPLANTATION UPDATED TO (B)(6) 2020. THIS REPORT IS FOR THE LEFT SIDE. . MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION COMPLETED ON (B)(6) 2020: DURING THE VISUAL EVALUATION, AN ANOMALY WAS OBSERVED ON THE POSTERIOR VIEW OF THE DEVICE CONSISTENT WITH A CREASE/FOLD. A TEAR MEASURING APPROXIMATELY 0.3 CM WAS ALSO OBSERVED WITHIN THE CREASE/FOLD. THE EVALUATION DETERMINED THAT THE LOSS OF SHELL INTEGRITY IS CONSISTENT WITH A CREASE FOLD DEFLATION OF THE IMPLANT SHELL, WHICH IS A KNOWN INHERENT RISK OF SALINE-FILLED MAMMARY PROSTHESIS. DEFLATION CAN OCCUR AT ANY TIME AFTER IMPLANTATION, BUT IT IS MORE LIKELY TO OCCUR THE LONGER THE IMPLANT IS IMPLANTED. CREATING WRINKLES OR FOLDS SHOULD BE AVOIDED DURING IMPLANTATION OR OTHER PROCEDURES AS IT CAN RESULT IN DEFLATION AT A LATER TIME. BREAST IMPLANTS MAY ALSO SIMPLY WEAR OUT OVER TIME. EACH DEVICE IS VISUALLY INSPECTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. 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/RUPTURE 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 AUGUST 21 2020: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

    AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. IT IS UNKNOWN AT THIS TIME IF THE DEVICE WILL BE MADE AVAILABLE FOR RETURN. AS A RESULT, 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 PERFORMED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: NA. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH MENTOR SMOOTH ROUND MODERATE PROFILE 375CC SALINE BREAST IMPLANTS WHICH THE LEFT SIDE DEFLATED, AND THE RIGHT SIDE HAS ISSUE WITH CAPSULAR CONTRACTURE BAKER GRADE II AFTER IMPLANTATION. THE ISSUE WAS CONFIRMED BY THE PHYSICIAN. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561006 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 3501660 240170 00081317001270

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other| R