BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEME MAMMARY PROSTHESIS

    MDR report key: 35733 · Received July 1, 1996

    Report

    Report Number
    35733
    Event Type
    Injury
    Date Received
    July 1, 1996
    Date of Event
    May 3, 1996
    Report Date
    June 28, 1996
    Manufacturer
    MEDICAL ENGINEERING CORP.
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RIGHT BREAST PROSTHESIS RUPTURED AND SILICONE PRESENT IN CLOSE PROXIMITY TO SKIN. BREAST HAD BECOME QUITE FIRM AND UNCOMFORTABLE. EXCHANGE OF RIGHT BREAST PROSTHESIS WITH TOTAL CAPSULECTOMY AND REINSERTION OF SALINE-FILLED BREAST PROSTHESIS WERE PERFORMED ON 5/3/96.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEME MAMMARY PROSTHESIS Implant MAMMARY PROSTHESIS FTR MEDICAL ENGINEERING CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention