BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 13487675 · Received February 8, 2022

    Report

    Report Number
    1645337-2022-01376
    Event Type
    Injury
    Date Received
    February 8, 2022
    Date of Event
    December 1, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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 MANUFACTURING RECORD EVALUATION COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: DEFLATION. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON FEBRUARY 16, 2022, MENTOR BECAME AWARE THAT DATA WAS REPORTED INCORRECTLY AND MISSING FROM THE INITIAL REPORT. THE CATALOG NUMBER SHOULD HAVE BEEN REPORTED AS 3501640 (PREVIOUSLY REPORTED AS A HYPHENATED CODE). FURTHERMORE, THE PMA FOR THIS DEVICE WAS AVAILABLE AND IS P990075. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 275CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE PROSTHESIS. POST-OPERATIVELY, THE PATIENT HAD A PHYSICAL EXAM AND THE HEALTH PROFESSIONAL STATED THAT SALINE FLUID WAS LEAKING FROM BOTH BREAST PROSTHESES. AS SUCH, THE PATIENT WAS DIAGNOSED WITH BILATERAL DEFLATION OF THEIR BREAST PROSTHESES. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT ON (B)(6) 2022. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-01375 FOR THE CONTRALATERAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903428 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention