BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANT, SILICONE GEL

    MDR report key: 399194 · Received June 11, 2002

    Report

    Report Number
    399194
    Event Type
    Malfunction
    Date Received
    June 11, 2002
    Date of Event
    May 23, 2002
    Report Date
    June 3, 2002
    Manufacturer
    N/D
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PT STATUS POST BILATERAL SUBCUTANEOUS MASTECTOMY WITH ROUND BECKER IMPLANTS PRESENTS FOR REMOVAL AND REPLACEMENT OF RIGHT DEFLATED IMPLANT AND SCAR REVISION OF THE INFERIOR AREOLA OF THE BILATERAL BREASTS SECONDARY TO A LOSS OF THE NIPPLE-AREOLAR COMPLEX SECONDARY TO THE PRIOR PROCEDURES. THE RIGHT IMPLANT WAS RUPTURED, 13 X 14CM. THE LEFT IMPLANT WAS REMOVED INTACT, 13 X 13CM. MENTOR IMPLANTS WERE USED AS REPLACEMENT IMPLANTS. THE PT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANT, SILICONE GEL PROSTHESIS, MAMMARY, INTERNAL (L) AND (R) FWM N/D * *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other