BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR CORP

    MDR report key: 475645 · Received August 1, 2003

    Report

    Report Number
    475645
    Event Type
    Injury
    Date Received
    August 1, 2003
    Date of Event
    May 27, 2003
    Report Date
    August 1, 2003
    Manufacturer
    MENTOR CORP
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED TO HOSP FOR REMOVAL AND REPLACEMENT OF BILATERAL BREAST IMPLANTS SECONDARY TO RIGHT SIDE DEFLATION. A RENT ON THE POSTERIOR SURFACE OF THE RIGHT BREAST IMPLANT WAS FOUND AS THE APPARENT LEAKING AREA. PT AUTHORIZED IMPLANTS TO BE SENT TO MANUFACTURER-MENTOR INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR CORP SILTEX SALINE BREAST IMPLANTS FWM MENTOR CORP UNK 185318

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention