BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR H/S

    MDR report key: 1130504 · Received August 20, 2008

    Report

    Report Number
    MW5008044
    Event Type
    Injury
    Date Received
    August 20, 2008
    Report Date
    August 20, 2008
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IN 2008, PT WOKE UP AND RIGHT BREAST IMPLANT WAS DEFLATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR H/S SALINE FILLED MAMMARY PROSTHESIS FWM 159767

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention