BEUDAMED
    FDA Adverse Event Other Summary report: N

    SILASTIC II MAMMARY IMPLANT H. P.

    MDR report key: 11865 · Received March 8, 1994

    Report

    Report Number
    MW1000978
    Event Type
    Other
    Date Received
    March 8, 1994
    Date of Event
    April 15, 1992
    Report Date
    February 22, 1994
    Manufacturer
    DOW CORNING CORP.
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    EACH OF TWO DOUBLE LUMEN IMPLANTS LEAKED INTO THE OUTER SALINE ENVELOPE. PT'S RIB DISLOCATES AT SITE OF IMPLANTS. A SINGLE LEFT RIB MOVES OUT OF POSITION TO CENTER OF CHEST. DATE OF IMPLANT: 5/7/91, INFRAMAMMARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILASTIC II MAMMARY IMPLANT H. P. Implant GEL-SALINE LOW PROFILE ROUND FTR DOW CORNING CORP. HH011099

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other