BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEXTURED BREAST IMPLANTS

    MDR report key: 8504190 · Received April 10, 2019

    Report

    Report Number
    MW5085798
    Event Type
    Injury
    Date Received
    April 10, 2019
    Report Date
    April 8, 2019
    Manufacturer
    UNK
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DOUBLE MASTECTOMY WITH SILICONE TEXTURED IMPLANTS; 7 SURGERIES TOTAL. ONE IMPLANT HAD BEEN IN ROUGHLY 14 MONTHS. THE OTHER ONE SINCE (B)(6), THIS YEAR. SEPSIS AND HOSPITALIZED FOR OVER 3 WEEKS. MANY HEALTH ISSUES SINCE IMPLANTS PUT IN. RANGING FROM SEVERE HASHIMOTOS DISEASE, LOW GRADE FEVER DAILY. EXTREME PAIN IN MY ENTIRE BODY. EXTREME FATIGUE NO MATTER HOW MUCH SLEEP I GET. TERRIBLE MOODS, BLOOD WORK IS ALL BASICALLY NORMAL OTHER THAN MY TPO THYROID ANTIBODIES BETWEEN 500-1600. DEPRESSION, ANXIETY, 30 POUND WEIGHT LOSS. UNABLE TO EAT. HAIR LOSS, CHRONIC HIGH / LEG BACK PAIN. SWOLLEN NODES (CURRENTLY BEING WORKED UP FOR LYMPHOMA.) BIGGEST MISTAKE OF MY LIFE PUTTING THESE IMPLANTS IN. I FEEL AM SLOWLY DYING, A PAINFUL, CONFUSING DEATH AND NOBODY CAN HELP ME. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295396 TEXTURED BREAST IMPLANTS PROSTHESIS, BREAST, NONINFLATABLE INTERNAL, SILICONE GEL-FILLED FTR UNK
    295397 TEXTURED BREAST IMPLANTS PROSTHESIS, BREAST, NONINFLATABLE INTERNAL, SILICONE GEL-FILLED FTR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization| L| S