BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 1890140 · Received October 30, 2010

    Report

    Report Number
    1890140
    Event Type
    Malfunction
    Date Received
    October 30, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 29, 2010
    Manufacturer
    UNK
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FEMALE PT WITH RUPTURE OF SILICONE IMPLANT TO RIGHT BREAST. PT HAD IMPLANTS PLACED APPROX 8 YEARS PRIOR IN ANOTHER COUNTRY ((B)(4)). PRODUCT INFO UNAVAILABLE. BILATERAL IMPLANTS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN SILICONE BREAST IMPLANT FTR UNK UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other