BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEXTURED SILICONE GEL GUMMY IMPLANT

    MDR report key: 9920578 · Received April 2, 2020

    Report

    Report Number
    MW5094026
    Event Type
    Injury
    Date Received
    April 2, 2020
    Date of Event
    July 24, 2014
    Report Date
    March 31, 2020
    Manufacturer
    ALLERGAN
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MADE OTHER CONDITIONS WORSE; ALLERGAN TEXTURED GUMMY BEAR NATRELLE 290CC IMPLANTS. AUGMENTATION SURGERY 2014. ANXIETY CHRONIC FATIGUE, CHRONIC DRY EYE, JOINT PAIN, HEART PALPITATIONS, DIVERTICULITIS, MULTIPLE CONCUSSIONS, CHRONIC CONGESTION, DRY SKIN, BRAIN FOG, MEMORY, CAN'T FIND WORDS I'M WANTING TO SAY, SURGERIES- 2016 36" LEFT HEMICOLECTOMY, 2016 ATTACHED COLON TO SPINE, OBSTRUCTION, LYSES OF ADHESIONS, 2016 9" SMALL INTESTINE RESECTION, 2016 LYSES OF ADHESION, 2017 RIGHT LABRAL TEAR (NO REASON FOR IT TO HAVE TORN); 2017 LYSES OF ADHESIONS, 2019 UTERINE HYDRO ABLATION, 2019 NASAL REPAIR. 26 MEDICATIONS AND SUPPLEMENTS, 8 SPECIALISTS-CARDIOLOGIST ENDOCRINOLOGIST NEUROLOGIST GASTROENTEROLOGIST DERMATOLOGIST IMMUNOLOGIST ORTHOPEDIST ORTHO SURGEON GASTRO SURGEON. SINCE IMPLANT MY HEALTH IS AWFUL. LOST MY JOB DUE TO HEALTH. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382780 TEXTURED SILICONE GEL GUMMY IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN 115
    382781 TEXTURED SILICONE GEL GUMMY IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN 115

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R| S