BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREAST IMPLANT RIGHT

    MDR report key: 16961134 · Received May 18, 2023

    Report

    Report Number
    MW5117670
    Event Type
    Injury
    Date Received
    May 18, 2023
    Date of Event
    June 12, 2013
    Report Date
    May 16, 2023
    Manufacturer
    ALLERGAN SALES, LLC.
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    RECEIVED BREAST IMPLANTS. HAVE HAD ONGOING HEALTH ISSUES SINCE. ONGOING MULTIPLE TESTS, MRI (MAGNETIC RESONANCE IMAGING), CT (COMPUTED TOMOGRAPHY), LAB TESTS, EKG (ELECTROCARDIOGRAM), ETC. REFERENCE REPORT: MW5117669.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650440 BREAST IMPLANT RIGHT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN SALES, LLC. 68 MP

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Disability NURTEC, FLEXERIL, TORADOL.| PROBIOTIC, OIL OF OREGANO, VIT D, BIOTIN.