BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLERGAN STYLE 20 HIGH PROFILE 260-CC

    MDR report key: 8366559 · Received February 21, 2019

    Report

    Report Number
    MW5084302
    Event Type
    Injury
    Date Received
    February 21, 2019
    Date of Event
    May 7, 2017
    Report Date
    February 17, 2019
    Manufacturer
    ALLERGAN
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SINCE (B)(6) OF 2017 I HAVE NOTICED WEIRD SYMPTOMS THAT I¿VE NEVER EXPERIENCED BEFORE. MY HEALTH IS GENERALLY EXCELLENT AND I AM NOT TAKING ANY MEDICATIONS OR HAD ANY PAST SURGERIES OTHER THAN BREAST AUGMENTATION. I CAN NEVER GET ENOUGH SLEEP I AM SO FATIGUED MY BODY ACHES ALL OVER I HAVE WHITE LIGHTS THAT GO ACROSS MY EYES, ANXIETY THAT I¿VE NEVER EXPERIENCED BEFORE. TINGLING IN MY LIMBS. HORRIBLE MEMORY LOSS AND WORD RECOGNITION. I AM UNBALANCED ESPECIALLY IN THE MORNING. BODY TEMPERATURE FLUCTUATIONS, HEART PALPITATIONS, URINE LEAKAGE, LIGHT AND SOUND SENSITIVITY, SNARKINESS, CONSTANT SINUS DRAINAGE, HORRIBLE DRY MOUTH, CANDIDA RINGING IN MY EARS, PLUS SOME OTHER THINGS. DOING CONSULTATIONS FOR EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153875 ALLERGAN STYLE 20 HIGH PROFILE 260-CC PROSTHESIS, BREAST, NONINFLATABLE, SILICONE GEL-FILLED FTR ALLERGAN
    153876 ALLERGAN STYLE 20 HIGH PROFILE 260-CC PROSTHESIS, BREAST, NONINFLATABLE, SILICONE GEL-FILLED FTR ALLERGAN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Disability