BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE FILLED BREAST IMPLANT

    MDR report key: 8374329 · Received February 26, 2019

    Report

    Report Number
    MW5084427
    Event Type
    Injury
    Date Received
    February 26, 2019
    Date of Event
    February 6, 2019
    Report Date
    February 22, 2019
    Manufacturer
    ALLERGAN
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    RI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    NIGHT SWEATS, HOT ALL DAY, I¿M FEELING LIKE I¿M GOING THROUGH MENOPAUSE AND I¿M ONLY (B)(6). NO ENERGY, I¿M VERY PHYSICALLY FIT, WORKOUT EVERY DAY, DO 8 MILE WALKS, BOX AND NOW I¿VE BEEN SO TIRED JUST TO GO DO A LITTLE SHOVELING. I¿M WIPED OUT ALL DAY. MY UNDER ARMS, SIDE BREAST ARE ITCHY, SWOLLEN, HURT TO TOUCH OR NOT TOUCH. I DON¿T HAVE A GOOD IMMUNE SYSTEM BECAUSE I HAVE THYROID DISEASE BUT MY LAST TEST, IT¿S BEEN NORMAL THIS WHOLE YEAR. I¿M ON MEDICATION BUT I HAVE GREAT ENERGY, WORKOUT, TAKE CARE OF 3 KIDS AND I¿M IN SCHOOL BUT SINCE I GOT THESE IMPLANTS I¿VE HAD NO ENERGY. IT¿S BEEN AROUND 2-3 MONTHS WITH THESE IMPLANTS AND I GOT THEM FOR HAVING A BREAST CANCER GENE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162174 NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL SILICONE GEL-FILLED FTR ALLERGAN 410CC FX-410410
    162175 NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL SILICONE GEL-FILLED FTR ALLERGAN 410CC

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other| S