BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

    MDR report key: 11646718 · Received April 11, 2021

    Report

    Report Number
    1645337-2021-03902
    Event Type
    Injury
    Date Received
    April 11, 2021
    Date of Event
    May 1, 2018
    Report Date
    March 18, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001416
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. IT IS UNKNOWN AT THIS TIME IF THE DEVICE WILL BE MADE AVAILABLE FOR RETURN. AS A RESULT, 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: N/A. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION WITH 350CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANTS EXPERIENCED AUTOIMMUNE DISORDER OF HASHIMOTO¿S DISEASE POSTOPERATIVELY. THE PATIENT REPORTED SUFFERING UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING MIGRAINES, FATIGUE, HAIR LOSS, RASHES, ROSACEA, FEVERS, FOOD SENSITIVITY AND ALLERGIES, BLURRY VISION, BLOATING, SWELLING, BREASTS WERE PAINFUL AND HOT TO THE TOUCH, PAIN UNDER ARM, DIFFICULTY BREATHING, BRAIN FOG, MEMORY PROBLEMS, JOINTS PAIN AND INFLAMMATION, PAIN AND NUMBNESS ON HANDS, BURNING AND PAINFUL SCALP, HEART PALPITATION, BACK PROBLEMS, TINNITUS, INSOMNIA DUE TO PAIN, AND ANXIETY. HASHIMOTO¿S DISEASE WAS DIAGNOSED VIA BLOODWORK, AND CONFIRMED BY ENDOCRINOLOGIST. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE RIGHT-SIDED IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544290 MENTOR SMOOTH ROUND MODERATE PLUS PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 3502350 6401487 00081317001416

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other