BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILASTIC (R) MAMMARY IMPLANT

    MDR report key: 79992 · Received March 25, 1997

    Report

    Report Number
    1816403-1997-00447
    Event Type
    Injury
    Date Received
    March 25, 1997
    Date of Event
    August 24, 1989
    Report Date
    March 31, 1992
    Manufacturer
    DOW CORNING CORP.
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN'S NOTE OF AUGUST 24, 1989 STATES PT FEELS A HARD LUMP IN THE LEFT LATERAL BREAST. PHYSICIAN FEELS THIS WAS CAUSED BY A COMBINATION OF SCAR TISSUE IN AN AREA WHERE THE BREAST TISSUE HAD BEEN THINNED FROM THE BIOPSY AND BECAUSE OF THIS THINNING OF THE BREAST TISSUE THE IMPLANT IS MORE PALPABLE. THERE MAY ALSO BE SOME MORE SUPERFICIAL SCAR TISSUE WHICH CONTRIBUTES TO THE FEELING OF A MASS PRESENT. UPON REMOVAL THERE WAS NO EVIDENCE OF RUPTURE, LEAKAGE OR GEL BLEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILASTIC (R) MAMMARY IMPLANT Implant MAMMARY IMPLANT, GEL FILLED FTR DOW CORNING CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other| R