BEUDAMED
    FDA Adverse Event Other Summary report: N

    CUI CORP.

    MDR report key: 271587 · Received March 23, 2000

    Report

    Report Number
    MW1018525
    Event Type
    Other
    Date Received
    March 23, 2000
    Report Date
    March 22, 2000
    Manufacturer
    MCGHAN MEDICAL CORP.
    Product Code
    FTR
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    1990 - BILATERAL BREAST AUGMENTATION W/SILICONE GEL IMPLANTS - SUBGLANDULAR 320CC. TEN YEARS LATER, DESIRES REVISION MILD CAPSULATION NOTED. 1 MONTH LATER PT UNDERWENT BILATERAL CAPSULECTOMY W/REMOVAL OF INTACT SILICONE GEL IMPLANTS. PT AUGMENTED WITH 350CC. MENTOR SILICONE GEL IMPLANTS BILATERALLY. NO PROBLEMS. IMPLANTS GIVEN TO PT PER REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUI CORP. SILICONE MAMMARY IMPLANT FTR MCGHAN MEDICAL CORP. CUI UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other