BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILASTIC MAMMARY IMPLANT

    MDR report key: 304151 · Received November 6, 2000

    Report

    Report Number
    1816403-2000-00135
    Event Type
    Injury
    Date Received
    November 6, 2000
    Date of Event
    April 11, 1996
    Report Date
    July 13, 2000
    Manufacturer
    DOW CORNING CORPORATION
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RPTR ALLEGES PT UNDERWENT SURGICAL PROCEDURE WITH LEFT "MRM AT STAGE D LOBULAR CA IN SITU" AND UNDERWENT 2 STAGED RECONSTRUCTIONS WITH THE FIRST ONE BEING A 270CC. A 350CC REPLACEMENT WAS PUT IN NEXT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILASTIC MAMMARY IMPLANT MAM IMP GEL-FILLED FTR DOW CORNING CORPORATION * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other| S