BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCGHAN MEDICAL CORP

    MDR report key: 292080 · Received August 22, 2000

    Report

    Report Number
    MW1019768
    Event Type
    Injury
    Date Received
    August 22, 2000
    Report Date
    June 18, 2000
    Manufacturer
    MCGHAN MEDICAL CORP
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AUGMENTED WITH SILICONE GEL MAMMARY IMPLANTS. IMPLANTS AND CAPSULES REMOVED. RT IMPLANT WAS RUPTURED. AUGMENTED WITH BIL SALINE MAMMARY IMPLANTS. SIX YEARS LATER PT NOTICED DEFLATED L IMPLANT. PT UNDERWENT REMOVAL OF DEFLATED L SALINE IMPLANT AND CAPSULECTOMY. PT AUGMENTED WITH MCGHAN SALINE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCGHAN MEDICAL CORP SALINE MAMMARY IMPLANT FWM MCGHAN MEDICAL CORP LEFT BREAST GI 3565

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention