BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SALINE BREAST IMPLANTS

    MDR report key: 8142467 · Received December 6, 2018

    Report

    Report Number
    MW5081953
    Event Type
    Injury
    Date Received
    December 6, 2018
    Date of Event
    April 1, 2007
    Report Date
    December 6, 2018
    Manufacturer
    MENTOR
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CONSISTENT PAIN IN RIGHT BREAST DUE TO SCAR TISSUE, CONTINUOUS SWELLING IN BREAST AND EXTREMITIES, SEVERE IMMUNE RESPONSE AGAINST MY WHOLE BODY, QUALITY OF LIFE SEVERELY AFFECTED. OVER $(B)(6) IN LAB WORK ALONE IN 2017; 50+LB WEIGHT GAIN, EXTREME SWELLING, SEVERE AUTOIMMUNE RESPONSE TO FOREIGN OBJECT BUT NO SPECIFIC DIAGNOSIS AS TO A DISEASE OTHER THAN IMPLANT RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979536 SALINE BREAST IMPLANTS PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR
    979537 SALINE BREAST IMPLANTS PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Disability