BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANT, SILICONE GEL (R) (L)

    MDR report key: 366551 · Received December 17, 2001

    Report

    Report Number
    366551
    Event Type
    Malfunction
    Date Received
    December 17, 2001
    Date of Event
    December 12, 2001
    Report Date
    December 17, 2001
    Manufacturer
    N/D
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERWENT A BREAST RECONSTRUCTION WITH SUBMUSCULAR SILICONE GEL IMPLANTS. PT HAS DEVELOPED A SEVERE CAPSULAR CONTRACTURE. THE DECISION WAS MADE TO PROCEED WITH REVISION OF THE RECONSTRUCTION. THE RIGHT SIDE WAS SURGICALLY ADDRESSED FIRST. THE GEL AND RUPTURED SHELL OF THE IMPLANT WERE REMOVED. THERE WAS A VERY TIGHT CAPSULAR CONTRACTURE AND CALCIFIC CONTRACTURE OF THE RIGHT SIDE. THE PROCEDURE WAS REPEATED ON THE LEFT SIDE. A RUPTURED GELATINOUS IMPLANT WAS REMOVED. THERE WASN'T ANY CALCIFIC CONTRACTURE, JUST SIGNIFICANT CAPSULAR CONTRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56965 IMPLANT, SILICONE GEL (R) (L) PROSTHESES, MAMMARY, INTERNAL FTR N/D NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other