BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

    MDR report key: 10643566 · Received October 7, 2020

    Report

    Report Number
    1645337-2020-12620
    Event Type
    Injury
    Date Received
    October 7, 2020
    Date of Event
    July 23, 2019
    Report Date
    September 16, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001409
    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. (B)(4). (B)(6). NOTE: AFTER IMPLANTATION, THE PATIENT HAD A REVISION WITH CAPSULE, THE HEALTHCARE PROFESSIONAL ADJUSTED ONE OF HER IMPLANTS. UNKNOWN SIDE. LEFT SIDE WAS USED AS A DEFAULT IMPLANT FOR SURGICAL INTERVENTION. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 325CC ON THE LEFT BREAST IMPLANT AND WITH MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 350CC ON THE RIGHT BREAST IMPLANT AND SUFFERED FROM BILATERAL NEOPLASM MALIGNANT, GENERALIZED ILLNESS SYMPTOMS, SURGICAL INTERVENTION ON THE LEFT BREAST IMPLANT. THE PATIENT EXPERIENCED PAIN, DISCOMFORT, LYMPHOMA, MUSCLE PAIN, BRAIN FOG, CHRONIC FATIGUE, GASTRO-INTESTINAL PROBLEMS, UPSET STOMACH , HAIR LOSS, NIGHT SWEATS, A LUMP CAME OUT OF NECK, BREAST IS SORE ON THE SIDES, FREQUENT URINATION, RINGING IN EARS, NON-STOP FATIGUE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH IS FOR THE LEFT BREAST IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1109162 MENTOR SMOOTH ROUND MODERATE PLUS PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 3502325 6447701 00081317001409

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other