BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEFT SALINE BREAST IMPLANT

    MDR report key: 1862060 · Received September 30, 2010

    Report

    Report Number
    1862060
    Event Type
    Malfunction
    Date Received
    September 30, 2010
    Date of Event
    August 17, 2010
    Report Date
    September 30, 2010
    Manufacturer
    ALLERGAN
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ONE BREAST IMPLANT HAD A PREMATURE RUPTURE OF IMPLANT RESULTING IN NEED FOR FURTHER SURGERY. SHE HAD RUPTURE OF HER LEFT SALINE IMPLANT ABOUT A YEAR AGO AND PRESENTS NOW DUE TO ASYMMETRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEFT SALINE BREAST IMPLANT IMPLANT - BREAST FWM ALLERGAN NA 1239001

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR