BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR

    MDR report key: 1061877 · Received June 16, 2008

    Report

    Report Number
    MW5007347
    Event Type
    Injury
    Date Received
    June 16, 2008
    Date of Event
    June 9, 2008
    Report Date
    June 16, 2008
    Manufacturer
    MENTO CORP., CORPORATE OFFICE
    Product Code
    LCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REMOVAL OF IMPLANT ALLODERM WITH IMMEDIATE RECONSTRUCTION WITH IMPLANT AND ALLODERM. AT APPROXIMATELY ONE MONTH LATER: OPEN CAPSULECTOMY WITH REMOVAL OF EXPANDER - CAPSULOTOMY (R) BREAST. TREATED WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR BREAST TISSUE EXPANDER LCJ MENTO CORP., CORPORATE OFFICE

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention