BEUDAMED
    FDA Adverse Event Summary report: N

    SURGITEK MAMMARY IMPLANTS

    MDR report key: 84401 · Received July 2, 1996

    Report

    Report Number
    84401
    Date Received
    July 2, 1996
    Manufacturer
    SURGITEK DIV OF CABOT MEDICAL ENGINEERING CORP
    Product Code
    FTR
    Report Source
    User Facility report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    SILASTIC MAMMARY IMPLANT ON LEFT BREAST WAS RUPTURED. HAD AUGMENTATION MAMMOPLASTY, BILATERAL, IN 1985. THESE ARE BOTH CO BRAND PRODUCTS. BOTH MAMMARY IMPLANTS REMOVED 2/13/96 (RT NOT RUPTURED) AND BOTH REPLACED WITH SALINE IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGITEK MAMMARY IMPLANTS Implant MAMMARY IMPLANTS FTR SURGITEK DIV OF CABOT MEDICAL ENGINEERING CORP NA *

    Patients

    Seq Age Sex Outcome Treatment
    1 *