BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 8274206 · Received January 24, 2019

    Report

    Report Number
    1645337-2019-08109
    Event Type
    Injury
    Date Received
    January 24, 2019
    Date of Event
    December 4, 2018
    Report Date
    January 23, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001256
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2019, IT WAS REPORTED TO MENTOR THAT A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE (B)(4) NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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: A SALINE MENTOR SMOOTH ROUND MODERATE PROFILE 325CC , CATALOG NUMBER 3501650, SERIAL NUMBER (B)(4), LOT NUMBER 5830771. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A SALINE MENTOR SMOOTH ROUND MODERATE PROFILE 325CC AND EXPERIENCED SPONTANEOUS DEFLATION AND PTOSIS ON THE LEFT SIDE. THE PATIENT EXPERIENCED CAPSULAR CONTRACTURE ON THE RIGHT BREAST IMPLANT. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 350CC, CATALOG NUMBER 3502350, SERIAL NUMBER (B)(4), LOT NUMBER 7630416 ON THE RIGHT BREAST IMPLANT AND SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 350CC , CATALOG NUMBER 3502350, SERIAL NUMBER (B)(4), LOT NUMBER 7630416 ON THE LEFT BREAST IMPLANT ON (B)(6) 2019. THERE WERE NO COMPLICATIONS AFTER THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67777 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5857880 00081317001256

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other| R