BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCGHAN 153 3600CC

    MDR report key: 9341304 · Received November 18, 2019

    Report

    Report Number
    MW5091150
    Event Type
    Injury
    Date Received
    November 18, 2019
    Date of Event
    January 16, 2017
    Report Date
    November 17, 2019
    Manufacturer
    ALLERGAN
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I RECEIVED MCGHAN IMPLANTS STYLE 153 360 CC IN (B)(6) 2002, WENT TO PLASTIC SURGEON IN (B)(6) 2012 REQUESTING EXPLANT AND HAS WAS NOT OPEN TO THIS DUE TO "UNACCEPTABLE AESTHETIC LOOK". I HAD STARTED HAVING NEUROLOGIC SYMPTOMS INCLUDING WEAKNESS, NUMBNESS AND TINGLING, ABNORMAL GAIT. HE EXCHANGED IMPLANTS FOR STYLE 10 180 CC IN (B)(6) 2012. I CONTINUED TO WORSEN WITH SYMPTOMS INCLUDING NEW ONSET EOSINOPHILIC ESOPHAGITIS AND MULTIPLE FOOD ALLERGIES, TINNITUS, VERTIGO, DOUBLE VISION, NEW ONSET HEADACHES AND ULTIMATELY RECEIVED MULTIPLE EGD'S FOR DYSPHAGIA AND EOE AND AN MRI OF THE BRAIN DUE TO NEUROLOGIC SYMPTOMS AND HAVE BEEN UNDER THE CARE OF A NEURO OPHTHALMOLOGIST SINCE (B)(6) OF 2019. I HAD A BREAST EXPLANT AND CAPSULECTOMY ON (B)(6) 2019. MULTIPLE LAB TESTS, MRI OF THE BRAIN, EMG, EGD'S, ALLERGY TESTING, VISITS TO A NEUROLOGIST, NEURO OPHTHALMOLOGIST, ALLERGIST AND GASTROENTEROLOGIST. MRI NEGATIVE, EGD BIOPSY CONFIRMS EOSINOPHILIC ESOPHAGITIS, LAB TESTS LARGELY NEGATIVE, EMG NEGATIVE, DOUBLE VISION HAS NOT CORRECTED AND NOW REQUIRES PRISMS, ALLERGY TESTING SHOWS MULTIPLE NEW ONSET ALLERGIES TO FOODS THAT I HAVE NEVER HAD BEFORE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1131011 MCGHAN 153 3600CC PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN 576687
    1131012 MCGHAN 153 3600CC PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN
    1131013 MCGHAN STYLE 10 180CC PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN
    1131014 MCGHAN STYLE 10 180CC PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Disability