BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 7952239 · Received October 10, 2018

    Report

    Report Number
    1645337-2018-06081
    Event Type
    Injury
    Date Received
    October 10, 2018
    Date of Event
    September 10, 2018
    Report Date
    September 11, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001263
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: TWO DEVICES WERE RETURNED AT MENTOR WITHOUT FLUID. WHITE MATERIAL WAS OBSERVED WITHIN THE PRODUCTS AND ON BOTH SHELL SURFACES. LEAK TESTING WAS PERFORMED ACCORDING WITH MENTOR PROCEDURES AND IT REVEALED LEAKAGE AT THE VALVE ON BOTH IMPLANTS. NO OTHER ANOMALIES WERE DISCOVERED. THE COMPLAINT WAS CONFIRMED SINCE A RUPTURE WAS FOUND ON THE DEVICE. HOWEVER, AT THIS POINT IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF SUCH DAMAGE OR THE ETIOLOGY OF THE. THE DEVICE HISTORY RECORD (DHR) OF LOT NUMBERS 1010960 AND 1003026 WERE REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THESE DHR REVIEW VERIFIES THAT THE DEVICES WERE 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. CONCOMITANT MEDICAL PRODUCTS: RIGHT MENTOR SMOOTH ROUND MODERATE PROFILE 350CC SALINE PROSTHESIS, CATALOG: 3501655, SERIAL NUMBER: (B)(4), LOT: 1010960. 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 A MENTOR SMOOTH ROUND MODERATE PROFILE 350CC SALINE PROSTHESIS. DEFLATION ON THE LEFT BREAST PROSTHESIS WAS DIAGNOSED POST PROCEDURE THROUGH A PHYSICAL EXAMINATION. AS A RESULT, THE BREAST PROSTHESIS WAS EXPLANTED FROM THE PATIENT ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792252 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 1003026 00081317001263

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention