BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEL FILLED MAMMARY IMPLANT

    MDR report key: 40233 · Received September 26, 1996

    Report

    Report Number
    1816403-1996-00098
    Event Type
    Injury
    Date Received
    September 26, 1996
    Date of Event
    August 15, 1996
    Report Date
    August 27, 1996
    Manufacturer
    DOW CORNING CORP
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    REPORTS ALLEGES PATIENT'S MAMMOGRAM OF AUG. 15, 1996 SHOWED BOTH IMPLANTS WERE RUPTURED. REPORT ALSO STATES DURING REMOVAL SURGERY THE RIGHT IMPLANT WAS FOUND TO HAVE A PIN HOLE WITH A SLICK COVERING OVER THE ENTIRE SURFACE OF THE IMPLANT AND ON THE LEFT SIDE THERE WAS A COMPLETE RUPTURE OF THE IMPLANT WITH FREE SILICONE LINING THROUGHOUT THE POCKET. A COMPLETE CAPSULECTOMY WAS CARRIED OUT ON BOTH SIDES.

    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 48 YR Required Intervention