BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 13972909 · Received April 1, 2022

    Report

    Report Number
    1645337-2022-03634
    Event Type
    Injury
    Date Received
    April 1, 2022
    Date of Event
    November 29, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001232
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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: MATERIAL RUPTURE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON JULY 19, 2022, THE MENTOR FAILURE ANALYSIS LAB RECEIVED A 275CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE (CATALOG: 3501640 LOT: 5801541 SN: (B)(6)). AFTER MULTIPLE FOLLOW-UPS, NO CLARIFYING INFORMATION WAS MADE AVAILABLE. THE SUSPECT DEVICE WAS UPDATED. ON AUGUST 7, 2022, THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR THEN CONDUCTED A VISUAL INSPECTION AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT THE SAL SMOOTH RND DIAP 275CC BREAST IMPLANT WAS FOUND TO HAVE AN AREA OF MISSING MATERIAL ON THE ANTERIOR VIEW MEASURING APPROXIMATELY 3.3 X 1.4 CM. MICROSCOPIC EXAMINATION WAS PERFORMED ON THE EDGES OF THE TEAR, AND PARALLEL STRIATIONS WERE FOUND IN AN AREA OF THE MISSING MATERIAL, MEASURING LESS THAN 0.1 CM. PARALLEL STRIATIONS ARE CONSISTENT WITH MARKINGS MADE BY A SHARP OBJECT PERFORATING THE IMPLANT SHELL. THE CAUSE IN THE REMAINING AREA OF THE TEAR COULD NOT BE IDENTIFIED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. AS PART OF MENTOR¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 275CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT SUFFERED SPONTANEOUS LEFT BREAST IMPLANT DEFLATION. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT ON (B)(6) 2022. THE REPLACEMENT DEVICES WERE: (LEFT) 300CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE CATALOG: 3501645 LOT: 9679257 SN: (B)(4) AND (RIGHT) 300CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE CATALOG: 3501645 LOT: 9679257 SN: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709123 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 3501640 5801541 00081317001232

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention