BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILASTIC MAMMARY PROSTHESIS CRONIN ROUND NFP SOFT

    MDR report key: 36642 · Received August 30, 1996

    Report

    Report Number
    1816403-1996-00006
    Event Type
    Injury
    Date Received
    August 30, 1996
    Date of Event
    May 2, 1996
    Report Date
    August 2, 1996
    Manufacturer
    DOW CORNING CORP.
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT ALLEGES RECEIVING IMPLANTS ON FEB. 25, 1974. MAMMOGRAM PERFORMED ON MAY 2, 1996 SHOWS A NEWLY DEVELOPED LATERAL BULGING WITH DOUBLE DENSITY ALONG THE MARGIN SEEN ON THE CRANIOCAUDED VIEW ON THE LEFT SIDE. POSSIBILITY OF INTRACAPSULAR RUPTURE CANNOT BE EXCLUDED WITH CERTAINTY. PATIENT ALLEGES CONSULTING WITH ORIGINAL PLASTIC SURGEON AND GENERAL PRACTITIONER; BOTH ADVISED REMOVAL OF IMPLANTS. PATIENT HAD REMOVAL ON AUG. 15, 1996.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILASTIC MAMMARY PROSTHESIS CRONIN ROUND NFP SOFT Implant MAMMARY IMPLANT, GEL-FILLED FTR DOW CORNING CORP. NA HH0385

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other| R