BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE # 5

    MDR report key: 3085330 · Received February 15, 2006

    Report

    Report Number
    3085330
    Event Type
    Injury
    Date Received
    February 15, 2006
    Date of Event
    February 9, 2006
    Report Date
    February 15, 2006
    Manufacturer
    SEE # 5
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REMOVAL OF RUPTURED SALINE BREAST IMPLANTS. IMPLANTS MARKED AS FOLLOWS: RIGHT - PIT 325CC (B)(4), LEFT PIT 325CC (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEE # 5 SALINE BREAST IMPLANTS FWM SEE # 5 UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R