BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEL FILLED MAMMARY IMPLANT

    MDR report key: 46511 · Received October 30, 1996

    Report

    Report Number
    1816403-1996-00209
    Event Type
    Injury
    Date Received
    October 30, 1996
    Date of Event
    October 1, 1982
    Report Date
    September 30, 1996
    Manufacturer
    DOW CORNING CORP
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED BREAST IMPLANTS IN 1980 OF AN UNK MFR. PT ALLEGES DISCOMFORT IN 10/1982, BLEEDING IN 8/1984 AND HARDENING IN 11/1984. PT ALSO ALLEGES HAVING ABOUT EIGHT SEPARATE OPERATIONS TO CORRECT PROBLEMS, ALL PROCEDURES INVOLVED REMOVAL AND REPLACEMENTS; HOWEVER, NO SPECIFIC DATES WERE GIVEN. REF. MW072674A, MW072674B.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other