BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLERGAN

    MDR report key: 1182825 · Received September 23, 2008

    Report

    Report Number
    1182825
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 23, 2008
    Manufacturer
    ALLERGAN, INC
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    PT HAD AN ABSCESS IN THE RT BREAST. A CULTURE WAS TAKEN AND AN INFECTION WAS NOTED. THE BREAST IMPLANT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLERGAN IMPLANT, BREAST FWM ALLERGAN, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR