BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 7519491 · Received May 16, 2018

    Report

    Report Number
    1645337-2018-02706
    Event Type
    Injury
    Date Received
    May 16, 2018
    Date of Event
    February 27, 2018
    Report Date
    May 2, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001294
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON 6/6/2018,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. 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: RIGHT BREAST IMPLANT SALINE MENTOR SMOOTH ROUND MODERATE PROFILE 475CC, SERIAL NUMBER (B)(4), CATALOG NUMBER 3501680, LOT NUMBER 5985513. (B)(4) .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) -YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH MENTOR SMOOTH ROUND MODERATE PROFILE 475CC SALINE BREAST IMPLANTS THAT THE RIGHT SIDE DEFLATED, AND BILATERAL ISSUE WITH CAPSULAR CONTRACTURE AFTER IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH RIGHT: CATALOG NUMBER 3501680, LOT NUMBER 6820115 AND SERIAL NUMBER (B)(4) AND LEFT WITH CATALOG 3501680, LOT NUMBER 6820115, AND SERIAL NUMBER WITH (B)(4) ON (B)(6) 2018. THIS REPORT IS FOR THE LEFT IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362663 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 6412002 00081317001294

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other