BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLERGAN MCGHAN 68 SALINE FILLED BREAST IMPLANT 390CC

    MDR report key: 8744133 · Received June 27, 2019

    Report

    Report Number
    MW5087682
    Event Type
    Injury
    Date Received
    June 27, 2019
    Date of Event
    October 1, 2013
    Report Date
    June 25, 2019
    Manufacturer
    MCGHAN / ALLERGAN
    Product Code
    FWM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    INAMED AESTHETICS ALLERGAN MCGHAN 68 SALINE FILLED BREAST IMPLANTS. CONSTANTLY PAINFUL, CHRONIC FATIGUE, CANDIDA OVERGROWTH, TENDER LYMPH NODES, MALABSORPTION ISSUES, THRUSH, JOINT PAIN, FEVER, MEMORY LOSS, BRAIN FOG, SUDDEN ALLERGIES TO GLUTEN, YEAST, DAIRY, SUGAR, LEAKY GUT, BODY ODOR CHEST AREA, WEIGHT GAIN 50 LBS. BEEN TO NUMEROUS DRS, HAD MANY TESTS. NO ONE CAN INDICATE WHERE TO "YEAST/MOLD" OVERGROWTH IS COMING FROM UNTIL ONE DR SUGGESTED THE BREAST IMPLANT AND CAPSULE BACTERIA BUILD UP INSIDE AND OUTSIDE THE IMPLANT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531660 ALLERGAN MCGHAN 68 SALINE FILLED BREAST IMPLANT 390CC PROSTHESIS, BREAST, INFLATABLE SALINE FWM MCGHAN / ALLERGAN 1221600
    531661 ALLERGAN MCGHAN 68 SALINE FILLED BREAST IMPLANT 390CC PROSTHESIS, BREAST, INFLATABLE SALINE FWM MCGHAN / ALLERGAN

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| S