BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

    MDR report key: 7343127 · Received March 15, 2018

    Report

    Report Number
    1645337-2018-01548
    Event Type
    Injury
    Date Received
    March 15, 2018
    Date of Event
    February 13, 2018
    Report Date
    February 15, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001423
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT BY MENTOR, THE DEVICE RETURNED WITHOUT FLUID. WHITE MATERIAL WAS OBSERVED WITHIN THE DEVICE. NO FOREIGN MATERIAL WAS OBSERVED ON THE SHELL SURFACE. DURING EXAMINATION, PRODUCT EVALUATION OBSERVED A CREASE ON THE POSTERIOR ASPECT. A RENT MEASURING APPROXIMATELY 0.3 CM WAS DISCOVERED WITHIN THE CREASE ON THE POSTERIOR ASPECT. 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 ORIGIN OF WHITE MATERIAL FOUND IN THE DEVICE. ALL THE IMPLANTS ARE 100% INSPECTED BEFORE LEAVING THE FACILITY. THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH MANUFACTURING. THE DEVICE HISTORY RECORD (DHR) OF LOT NUMBER 6950241 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. 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

    SINCE THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS, 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. 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: MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 375CC SALINE CATALOG #3502375 LOT #6965824 SN #(B)(4). 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. 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 MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 375CC SALINE BREAST PROSTHESES. DOCTOR'S PHYSICAL EXAMINATION DIAGNOSED THAT THE RIGHT BREAST PROSTHESIS HAD DEFLATED. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 375CC SALINE BREAST PROSTHESES ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185526 MENTOR SMOOTH ROUND MODERATE PLUS PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 6950241 00081317001423

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention