BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SALINE HIGH PROFILE

    MDR report key: 9410861 · Received December 3, 2019

    Report

    Report Number
    MW5091419
    Event Type
    Injury
    Date Received
    December 3, 2019
    Date of Event
    November 30, 2019
    Report Date
    December 2, 2019
    Manufacturer
    ALLERGAN
    Product Code
    FWM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I'VE HAD IMPLANTS SALINE BY ALLERGAN SINCE (B)(6) OF 2019. EVER SINCE I GOT THEM I FELT SICK, I WAS GOING TO REMOVE BUT I ENDED FEELING BETTER AND LEFT THEM. TWO MONTHS LATER I DECIDED TO WORK OUT BY JOGGING AN LATER THAT DAY I ENDED UP WITH MASSIVE DIZZINESS, WEAKNESS, DIARRHEA AND WENT TO HOSPITAL AND WAS TOLD MY WHITE BLOOD CELLS WERE HIGH AND I MIGHT HAVE HAD VERTIGO. HOWEVER DOCTOR DID NOT KNOW WHY I FELT THE WAY I FELT. THEN IN (B)(6) I DECIDED TO WORK OUT AGAIN BY DOING JUMPING JAX AND FELT SICK AGAIN SIMILAR SYMPTOMS. THIS TIME I FELT WEAK FOR DAYS, UNABLE TO SPEAK OR CONCENTRATE CERTAIN WORDS, COULDN¿T EVEN WALK WELL CERTAIN DAYS. I WENT TO HOSPITALS ALL RESULTS FINE. IM (B)(6) VERY HEALTHY AND THE ONLY THING IS I CAN THINK OF IS IT IS MY IMPLANTS, BAN THESE THINGS AS THEY ARE NOT HEALTHY FOR YOU. SHAKING, CONFUSION, BRAIN FOG. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1194306 SALINE HIGH PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE. FWM ALLERGAN
    1194307 SALINE HIGH PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE. FWM ALLERGAN

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other| S