BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 15547301 · Received October 5, 2022

    Report

    Report Number
    1645337-2022-11806
    Event Type
    Injury
    Date Received
    October 5, 2022
    Date of Event
    August 15, 2022
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001270
    PMA / PMN Number
    P990075
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: DEFLATION. (B)(4).

    Additional Manufacturer Narrative · 0

    A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 191562 NUMBER ON OCTOBER 21, 2022, AND NO NON-CONFORMANCE'S WERE IDENTIFIED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4) ON OCTOBER 26, 2022 MENTOR BECAME AWARE THAT THE INCORRECT MRE MANUFACTURING RECORD EVALUATION STATEMENT WAS MADE WITH THE INITIAL REPORT SUBMITTED. THE INCORRECT STATEMENT IS AS FOLLOWS: A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE CORRECT STATEMENT SHOULD HAVE BEEN: A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE MRE WAS NOT OBTAINED UNTIL (B)(6) 2022.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SMOOTH ROUND MODERATE PROFILE 375CC SALINE PROSTHESIS EXPERIENCED RIGHT SIDED DEFLATION WITH NO TRAUMA POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2247511 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 3501660 191562 00081317001270

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention