BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

    MDR report key: 7667565 · Received July 6, 2018

    Report

    Report Number
    1645337-2018-04113
    Event Type
    Injury
    Date Received
    July 6, 2018
    Date of Event
    January 1, 2018
    Report Date
    June 15, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ON 7/30/2018, MENTOR RECEIVED INFORMATION THAT IDENTIFIED THE INITIALLY REPORTED UNKNOWN DEVICE: BRAND NAME: MENTOR SMOOTH ROUND MODERATE PLUS PROFILE, PROCODE: FWM, COMMON DEVICE NAME: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE, CATALOG: 3502750, LOT: 5638845, UNIQUE IDENTIFIER (UDI): (B)(4), PMA/ 510(K): P990075. ON 7/23/2018, MENTOR RECEIVED ADDITIONAL INFORMATION: DATE OF EVENT: (B)(6) 2018. THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 7/23/2018. DEVICE EVALUATION SUMMARY: THE DEVICE WAS RECEIVED AT MENTOR WITHOUT FLUID. NO FOREIGN MATERIAL WAS OBSERVED WITHIN THE DEVICE OR ON THE SHELL SURFACE. THE PRODUCT EVALUATION TEAM DISCOVERED A RENT MEASURING APPROXIMATELY 0.3 CM WITHIN A 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. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED ON 8/1/2018, 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. 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

    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. SINCE NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD (DHR) REVIEW COULD BE PERFORMED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH AN UNKNOWN MENTOR SALINE PROSTHESIS. DEFLATION ON RIGHT BREAST PROSTHESIS WAS DIAGNOSED POST PROCEDURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 800CC GEL PROSTHESIS ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508895 MENTOR SMOOTH ROUND MODERATE PLUS PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5638845

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention