BEUDAMED
    FDA Adverse Event Summary report: N

    SURGITEK SILICONE BREAST IMPLANT

    MDR report key: 13886 · Received June 9, 1994

    Report

    Report Number
    MW1002411
    Date Received
    June 9, 1994
    Date of Event
    October 1, 1993
    Report Date
    April 13, 1994
    Manufacturer
    MEDICAL ENGINEERING CORP.
    Product Code
    FTR
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR HAD BREAST IMPLANTS INSERTED FOLLOWING MASTECTOMIES. THE RIGHT IMPLANT WAS INSERTED IN 7/87, AND THE LEFT ON 7/29/89. RPTR HAD PAIN AND INFLAMMATION BEHIND THE IMPLANTS STARTING IN 10/93. HER IMPLANTING PHYSICIAN THOUGHT IT MIGHT BE A PULLED MUSCLE. THE PAIN MIGRATED TO HER BACK, SIDES, ETC. ANOTHER TWO DRS PRESCRIBED ANTI-INFLAMMATORY MEDICATION AND PAIN PILLS. THE MEDICINES DID NOT SOLVE THE PROBLEM AND RPTR BECAME NEARLY IMMOBILE DUE TO PAIN THE WEEK BEFORE THE RUPTURE. ON 3/12, THE RIGHT IMPLANT RUPTURED AND BOTH WERE TAKEN OUT ON 3/16/94, AS RPTR AWAITED APPROVAL FROM THE INSURANCE CO. SHE ALSO HAD ONE CLOSED CAPSULOTOMY. BOTH IMPLANTS AT TIME OF RUPTURE WERE HARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGITEK SILICONE BREAST IMPLANT Implant FTR MEDICAL ENGINEERING CORP. 49937

    Patients

    Seq Age Sex Outcome Treatment
    1 *