BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 7557440 · Received May 31, 2018

    Report

    Report Number
    1645337-2018-03354
    Event Type
    Injury
    Date Received
    May 31, 2018
    Date of Event
    March 26, 2018
    Report Date
    May 11, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001287
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING WAS MISTAKENLY OMITTED FROM THE REPORT SUBMITTED ON 6/12/2018: THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED ON 6/11/2018, 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    ON 5/31/2018, MENTOR BECAME AWARE THAT THE PMA/510(K) WAS REPORTED INCORRECTLY IN THE INITIAL REPORT DATED 5/31/2018. THE CORRECT PMA/510(K) IS P990075. 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. A DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: LEFT MENTOR SMOOTH ROUND MODERATE PROFILE 425CC SALINE PROSTHESIS, CATALOG: 3501670, SERIAL NUMBER: (B)(4), LOT: 5685212. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) CAUCASIAN PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SMOOTH ROUND MODERATE PROFILE 425CC SALINE PROSTHESIS. DEFLATION ON THE RIGHT BREAST PROSTHESIS WAS DIAGNOSED POST PROCEDURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 400CC SALINE PROSTHESES ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399751 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5685212 00081317001287

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention