BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 503204 · Received December 15, 2003

    Report

    Report Number
    MW1030548
    Event Type
    Injury
    Date Received
    December 15, 2003
    Report Date
    December 9, 2003
    Manufacturer
    NA
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BILATERAL SILICONE GEL CAPSULAR CONTRACTURES OF IMPLANTS FROM 1985. 2003 PT. PRESENTS REQUESTING REMOVAL OF SILICONE IMPLANTS RIGHT AND LEFT BREAST.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention