BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEL FILLED MAMMARY IMPLANT

    MDR report key: 43312 · Received October 16, 1996

    Report

    Report Number
    1816403-1996-00158
    Event Type
    Injury
    Date Received
    October 16, 1996
    Date of Event
    December 2, 1994
    Report Date
    September 17, 1996
    Manufacturer
    DOW CORNING CORP
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PT ALLEGES RECEIVING A LEFT BREAST IMPLANT IN OCT 1991 AND A RIGHT BREAST IMPLANT IN DEC 1991 OF AN UNK MFR. PHYSICIAN'S LETTER STATES ON DEC 2, 1994 THE PT'S RIGHT PROSTHESIS WAS COMPLETELY DEFLATED AND NOT PALPABLE WITH NO RESIDUAL BREAST TISSUE PRESENT. THE LEFT BREAST HAD BAKER GRADE III CAPSULAR CONTRACTURE WITH PROSTHESIS SITUATED MEDIALLY AND TOO HIGH; THEREFORE. PT HAD REMOVAL AND REPLACEMENT OF BOTH IMPLANTS ON JAN 23, 1995 WITH SALINE DEVICES OF ANOTHER MFR. PT ALLEGES SUFFERING RHEUMATISM, SEVERE HIP PAINS, FEET PAINS, BRONCHITIS SOMETIMES 6-7 TIMES ANNUALLY, CYSTITIS, MIXED CONNECTIVE TISSUE DISEASE AND ATYPICAL RHEUMATIC SYNDROME. REFERENCE MW072498, WM072498A.

    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 68 YR Other| R