BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENTOR

    MDR report key: 1732857 · Received June 17, 2010

    Report

    Report Number
    MW5016428
    Event Type
    Malfunction
    Date Received
    June 17, 2010
    Manufacturer
    MENTOR
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DEFLATED RIGHT BREAST SALINE IMPLANT ((B)(6) 2001 IMPLANTED). NOTED BY PT - (B)(6) 2010. REPLACED (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR SALINE BREAST IMPLANT FWM MENTOR MENTOR SILTEX SALINE MAMMO PORTH 218233

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR