BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSTHESIS, MAMMARY, SILICONE GEL-FILLED, 325 CC

    MDR report key: 17898 · Received October 5, 1994

    Report

    Report Number
    17898
    Event Type
    Malfunction
    Date Received
    October 5, 1994
    Date of Event
    May 3, 1994
    Report Date
    October 5, 1994
    Manufacturer
    UNKNOWN
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    THE PT HAD BOTH MAMMARY PROSTHESES IMPLANTED IN THE EARLY 1980'S. SHE LATER DEVELOPED CAPSULAR CONTRACTURES WITH ACCOMPANYING DISCOMFORT. EVENTUALLY, THE BREASTS EXCESSIVELY DROOPED, GIVING THEM AN EXTREMELY ABNORMAL APPEARANCE. CORRECTION OF HER CONDITION REQUIRED SURGICAL REMOVAL OF THE MAMMARY PROSTHESES AND A MAMMOPLASTY. SALINE-FILLED PROSTHESES REPLACED THE EXPLANTED PROSTHESES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTHESIS, MAMMARY, SILICONE GEL-FILLED, 325 CC Implant BREAST IMPLANT FTR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other