BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE BREAST IMPLANT

    MDR report key: 14218716 · Received April 26, 2022

    Report

    Report Number
    MW5109374
    Event Type
    Injury
    Date Received
    April 26, 2022
    Date of Event
    September 25, 2013
    Report Date
    April 23, 2022
    Manufacturer
    ALLERGAN
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAVE SILICONE BREAST IMPLANTS. CAPSULAR CONTRACTURE. DIAGNOSED WITH LCIS AND ATYPICAL HYPERPLASIA. BRAIN FOG CHEST PAIN, EXTREME FATIGUE, ANXIETY, BACK PAIN. HAD MULTIPLE SETS MOST RECENT 9252013. HAD "(B)(6)" IN 2011 IN MY BREAST. SURGERY (B)(6) 2011 TO DRAIN. ALSO HAD "(B)(6)" IN BREAST IN 2011 TWICE ONCE (B)(6) HOSPITALIZED THEN (B)(6) SURGERY. ALSO NUMEROUS CORE NEEDLE BIOPSIES. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1444991 SILICONE BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN MCGHAN STYLE 10
    1444992 SILICONE BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN MCGHAN STYLE 10

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Other