BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR CORP SALINE BREAST IMPLANTS 350CC

    MDR report key: 8297273 · Received January 31, 2019

    Report

    Report Number
    MW5083641
    Event Type
    Injury
    Date Received
    January 31, 2019
    Date of Event
    May 16, 2012
    Report Date
    January 30, 2019
    Manufacturer
    MENTOR WORLDWIDE LLC
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAVE HAD ABOUT THREE EKGS IN EMERGENCY. BREAST IMPLANTS MAY BE THE CAUSE. NO REASON FOUND FOR HEART PALPITATIONS. WAS ON A HEART MONITOR AN ENTIRE MONTH. ALSO HAVE SHORTNESS OF BREATH, HAIR THINNING, MEMORY ISSUES, RAYNAUDS, MIGRAINES, EXTREME DIGESTIVE DISORDERS AND MORE. HOW WAS IT TAKEN OR USED ? INTRAMUSCULAR. DATE THE PERSON STOPPED TAKING OR USING THE PRODUCT: (B)(6) 2019. WHY WAS THE PERSON USING THE PRODUCT? COSMETIC ENHANCEMENT. LOT NUMBER 213669.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88322 MENTOR CORP SALINE BREAST IMPLANTS 350CC PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR WORLDWIDE LLC 313669
    88323 MENTOR CORP SALINE BREAST IMPLANTS 350CC PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR WORLDWIDE LLC 313669

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other