BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCGHAN/ALLERGAN

    MDR report key: 1711480 · Received June 3, 2010

    Report

    Report Number
    MW5016161
    Event Type
    Malfunction
    Date Received
    June 3, 2010
    Date of Event
    November 1, 2006
    Report Date
    May 26, 2010
    Manufacturer
    ALLERGAN, INC.
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SALINE IMPLANT DEFLATED IN (B) (6) 2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCGHAN/ALLERGAN BREAST IMPLANT FWM ALLERGAN, INC. 27-168271 G27443

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other