BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGITEK MAMMARY IMPLANT ROUND

    MDR report key: 35124 · Received July 22, 1996

    Report

    Report Number
    35124
    Event Type
    Malfunction
    Date Received
    July 22, 1996
    Date of Event
    August 2, 1995
    Report Date
    May 7, 1996
    Manufacturer
    MEDICAL ENGINEERING CORP.
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERWENT BILATERAL MASTECTOMY IN 1988 FOR ADENOCARCINOMA. SHE HAS COMPLETED BILATERAL BREAST RECONSTRUCTION. HER INITIAL RECONSTRUCTION WAS COMPLICATED BY PERIPROSTHETIC INFECTION. SHE HAD BILATERAL RECONSTRUCTIVE GEL-FILLED IMPLANTS OF 500 CC ON THE RIGHT AND 550 CC ON THE LEFT. SHE HAS BEEN PLAGUED BY MODEST CAPSULAR CONTRACTURE. PT HAS HAD PROGRESSIVE CAPSULAR CONTRACTION, NOT SEVERE, BUT TO THE POINT THAT IT IS CAUSING DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGITEK MAMMARY IMPLANT ROUND Implant MAMMARY IMPLANT ROUND ADJUSTABLE RECON 500/580CC FTR MEDICAL ENGINEERING CORP. * 77662-88B

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR