BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

    MDR report key: 10538738 · Received September 15, 2020

    Report

    Report Number
    1645337-2020-11681
    Event Type
    Injury
    Date Received
    September 15, 2020
    Date of Event
    November 6, 2019
    Report Date
    August 25, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001447
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED (B)(6) 2020, PATIENT HAS A PLANNED EXPLANTATION ON (B)(6) 2020. WEIGHT OF THE PATIENT IS 170.0 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. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: GENERALIZED ILLNESS H6 PATIENT CODE 3191: MEDICAL DEVICE REMOVAL MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    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). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO THAT A (B)(6) YEAR-OLD AFRICAN AMERICAN PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION SURGERY WITH TWO 425CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANTS EXPERIENCED ANXIETY ATTACKS, CHEST PAIN, MUSCLE JOINT PAIN, BRAIN FOG, DEPRESSION. SWEATING. VISION BLUR. INSOMNIA, NEUROPATHY AND BREAST IMPLANT ILLNESS POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002321 MENTOR SMOOTH ROUND MODERATE PLUS PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 3502425 6566230 00081317001447

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other| R