BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHYSICAL MEDICINE PRODUCTS

    MDR report key: 2425206 · Received January 23, 2012

    Report

    Report Number
    2425206
    Event Type
    Malfunction
    Date Received
    January 23, 2012
    Date of Event
    December 13, 2011
    Report Date
    December 19, 2011
    Manufacturer
    ALLERGAN IMPLANT 650CC
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011 07:52 PM, (B)(4) RIGHT BREAST IMPLANT EXCHANGE. BREAST IMPLANT DEFLATED AND HAD TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHYSICAL MEDICINE PRODUCTS FTR ALLERGAN IMPLANT 650CC

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR