BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

    MDR report key: 8453066 · Received March 26, 2019

    Report

    Report Number
    1645337-2019-09689
    Event Type
    Injury
    Date Received
    March 26, 2019
    Date of Event
    November 1, 2018
    Report Date
    March 4, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001478
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 9/24/2019, MENTOR BECAME AWARE THAT THE PATIENT IS CAUCASIAN. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: THE DEVICE WAS RECEIVED WITH NO FLUID. NO FOREIGN MATERIAL WAS OBSERVED WITHIN THE DEVICE OR ON THE SHELL SURFACE. DURING EVALUATION THE DEVICE APPEARED INTACT. NO ANOMALIES WERE DISCOVERED. MENTOR PRODUCTS ARE 100% VISUALLY INSPECTED PRIOR TO RELEASE IN ADDITION TO THOROUGH IN-PROCESS TESTING DURING SEVERAL STAGES OF THE MANUFACTURING PROCESS. A ROOT CAUSE OF THE FAILURE COULD NOT BE DETERMINED. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 6963789, AND NO NON-CONFORMANCE'S RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. ASYMMETRY MAY BE ATTRIBUTED TO ONE OR MORE OF THE FOLLOWING: CONTRACTURE OF THE FIBROUS CAPSULE, SEROMA OR HEMATOMA, DEVELOPMENT OF POSTOPERATIVE BREAST DYSPLASIA, UNILATERAL DISCREPANCY IN MUSCLE DEVELOPMENT, DEFLATION OF THE IMPLANT, INCORRECT CHOICE OF IMPLANT SHAPE OR SIZE, AND SURGICAL TECHNIQUE. ASYMMETRY IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR CURRENT 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. A MANUFACTURING RECORD EVALUATION (MRE) 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 500CC BREAST IMPLANTS AND EXPERIENCED BILATERAL PTOSIS AND DEFLATION ON THE RIGHT BREAST IMPLANT. AS A RESULT, PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH SALINE MENTOR SMOOTH ROUND MODERATE PROFILE 200CC, CATALOG NUMBER 3501625, LOT NUMBER 7626112, SERIAL NUMBER (B)(4) ON (B)(6)2019. THIS REPORT IS FOR THE LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247059 MENTOR SMOOTH ROUND MODERATE PLUS PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 6963789 00081317001478

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention