BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUMMY BEAR IMPLANT

    MDR report key: 8555284 · Received April 25, 2019

    Report

    Report Number
    MW5086194
    Event Type
    Injury
    Date Received
    April 25, 2019
    Date of Event
    September 30, 2007
    Manufacturer
    ALLERGAN INC
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AFTER LEFT MASTECTOMY, HAD GUMMY IMPLANTS BY ALLERGEN 410. I HAVE DEVELOPED PAIN, SWELLING, FOOD SENSITIVITIES, BRAIN FOG, CHRONIC FATIGUE, TIGHTENING OF SCAPULAR, NECK, SHOULDER AND PAIN DOWN MY L ARM, HEART PALPITATIONS, MEMORY LOSS, DECREASED VISION, SINUS AND ALLERGY PROBLEMS AND RIB PAIN WITH ONE RIB CURRENTLY BULGING. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343791 GUMMY BEAR IMPLANT PROSTHESIS, BREAST, NON INFLATABLE, INTERNAL SILICONE GEL-FILLED FTR ALLERGAN INC 410

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention