BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR CORP

    MDR report key: 323776 · Received March 29, 2001

    Report

    Report Number
    MW1021526
    Event Type
    Injury
    Date Received
    March 29, 2001
    Date of Event
    March 1, 2001
    Report Date
    March 29, 2001
    Manufacturer
    MENTOR CORP
    Product Code
    FWM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    REMOVAL AND REPLACEMENT OF RUPTURED SALINE FILLED BREAST IMPLANT. MENTOR IMPLANT REPLACED WITH A MCGHAN STYLE 40, CAT#25-40341, GEL FILLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13772 MENTOR CORP SALINE FILLED BREAST IMPLANT FWM MENTOR CORP 354-2625 153606

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention