BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR CORP.

    MDR report key: 16862 · Received July 12, 1994

    Report

    Report Number
    16862
    Event Type
    Injury
    Date Received
    July 12, 1994
    Date of Event
    July 7, 1994
    Report Date
    July 12, 1994
    Manufacturer
    MENTOR CORP.
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON 4/19/90, BILATERAL BREAST IMPLANTS, ON 7/7/94, EXPLANT OF BILATERAL BREAST IMPLANTS. LEFT IMPLANT WAS FOUND TO BE RUPTURED IWTH NO PROSTHESIS CAPSULE EVIDENT (ACCORDING TO PATHOLOGIST'S REPORT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR CORP. Implant BREAST IMPLANT FTR MENTOR CORP. 9000 ROUND LOW PROFILE GEL LOW 19244

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Disability RIGHT BREAST IMPLANT INTACT AT TIME OF REMOVAL| (7/7/94). SAME MODEL NUMBER, 300 CC LOT # 28872.