BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 9475209 · Received December 16, 2019

    Report

    Report Number
    1645337-2019-25358
    Event Type
    Injury
    Date Received
    December 16, 2019
    Date of Event
    November 19, 2019
    Report Date
    November 20, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001225
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MENTOR RECEIVED AN UPDATE TO THE EVENTS SUBMITTED IN THE INITIAL REPORT. THE COMPLAINT DEVICE HAS BEEN DISCARDED. AS A RESULT, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    MENTOR RECEIVED AN UPDATE TO THE EVENTS SUBMITTED IN THE INITIAL REPORT. 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. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    MENTOR RECEIVED AN UPDATE REGARDING THE EVENTS SUBMITTED IN THE PREVIOUS REPORTS. THE PATIENT HAD ALSO BEEN DIAGNOSED WITH LEFT-SIDED CAPSULAR CONTRACTURE (BAKER GRADE II). ON (B)(6) 2019, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACED WITH 175CC MENTOR SALINE BREAST IMPLANTS. THE LEFT-SIDED DEVICE HAS BEEN REPORTED IN MANUFACTURER REPORT NUMBER 1645337-2020-01957. 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 MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: DEFLATION. CONCOMITANT MEDICAL PRODUCTS: 250CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST IMPLANT (CATALOG NUMBER 3501635, SERIAL NUMBER (B)(4)). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH 250CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST IMPLANTS AND EXPERIENCED POSTOPERATIVE RIGHT-SIDED DEFLATION. THE DIAGNOSIS WAS CONFIRMED BY A PHYSICIAN UPON EXAMINATION. AS A RESULT, THE PATIENT'S IMPACTED DEVICE WAS EXPLANTED ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1270933 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 3501635 6519605 00081317001225

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention