BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR

    MDR report key: 358351 · Received October 24, 2001

    Report

    Report Number
    MW1023211
    Event Type
    Injury
    Date Received
    October 24, 2001
    Date of Event
    August 25, 2001
    Report Date
    October 24, 2001
    Manufacturer
    MENTOR CORP
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SALINE FILLED IMPLANT, MADE BY MENTOR CORP, LEAKED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47831 MENTOR SALINE FILLED MAMMARY PRODUCT FWM MENTOR CORP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| S