BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TRX BREAST IMPLANTS

    MDR report key: 10704553 · Received October 19, 2020

    Report

    Report Number
    MW5097333
    Event Type
    Injury
    Date Received
    October 19, 2020
    Date of Event
    March 8, 2017
    Report Date
    October 16, 2020
    Manufacturer
    ALLERGAN
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE BEEN STRUGGLING WITH FATIGUE, MIGRAINE, DIZZINESS AND A VARIETY OF OTHER SYMPTOMS. I HAVE BEEN DIAGNOSED WITH M.E AND MY HELEN HAS DETERIORATED OVER THE PAST 4 YEARS. I HAVE ONLY JUST COME ACROSS BREAST IMPLANT ILLNESS AND AL-IL. I HAVE ALLERGAN BREAST IMPLANTS AND AM NOW HAVING THEM EXPLANTED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1160028 INSPIRA TRX BREAST IMPLANTS PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN N-TRX340 1835862
    1160029 INSPIRA TRX BREAST IMPLANTS PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN N-TRX340 1835862

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Disability