BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR BREAST IMPLANT

    MDR report key: 8479402 · Received April 2, 2019

    Report

    Report Number
    MW5085537
    Event Type
    Injury
    Date Received
    April 2, 2019
    Report Date
    March 31, 2019
    Manufacturer
    MENTOR
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WENT TO EMERGENCY ROOM NUMEROUS TIMES FOR RAPID HEART BEAT, ASTHMA AND LOW HEMOGLOBIN. FDA SAFETY REPORT ID #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269675 MENTOR BREAST IMPLANT PROSTHESIS, BREAST FTR MENTOR
    269676 MENTOR BREAST IMPLANT PROSTHESIS, BREAST FTR MENTOR

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other| S