BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 8232332 · Received January 9, 2019

    Report

    Report Number
    1645337-2019-07843
    Event Type
    Injury
    Date Received
    January 9, 2019
    Date of Event
    December 10, 2018
    Report Date
    December 13, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001263
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2019, MENTOR BECAME AWARE THAT THE RIGHT IMPLANT WAS INTACT AND PATIENT HAD BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN. PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT ON (B)(6) 2019 WITH NATRELLE INSPIRA CATALOG #: SCX-525; S/N: (B)(4) ON THE RIGHT AND WITH NATRELLE INSPIRA CATALOG #: SCX-525; S/N: (B)(4) ON THE LEFT SIDE. THE DATE OF IMPLANT WAS CORRECTED TO (B)(6) 2012. THIS REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. IT IS UNKNOWN AT THIS TIME IF THE DEVICE WILL BE MADE AVAILABLE FOR RETURN. AS A RESULT, 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A SALINE MENTOR SMOOTH ROUND MODERATE PROFILE 350CC AND EXPERIENCED SPONTANEOUS BILATERAL DEFLATION AND PAIN. THE PATIENT FELT THE IMPLANTS GETTING SMALLER. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS IS FOR THE RIGHT SIDE IMPLANT, SEE MANUFACTURER REPORT NUMBER 1645337-2019-07844 FOR CONTRALATERAL PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24539 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 6625168 00081317001263

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other