BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILASTIC (R) MAMMARY IMPLANT

    MDR report key: 117756 · Received September 5, 1997

    Report

    Report Number
    1816403-1997-00762
    Event Type
    Injury
    Date Received
    September 5, 1997
    Date of Event
    December 12, 1985
    Report Date
    September 19, 1996
    Manufacturer
    DOW CORNING CORP.
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT ALLEGES TWELVE DAYS AFTER IMPLANTATION (I.E. DECEMBER 15, 1985) A SECOND SURGERY WAS PERFORMED ON HER LEFT SIDE DUE TO IMPLANT COMPLICATIONS. PHYSICIAN'S NOTE SHOWS PT HAD EVACUATION OF A HEMATOMA IN HER LEFT AXILLA AND UPON REINSERTION, THE IMPLANT RUPTURED.

    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 24 YR Other| R