BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANT, SILICONE GEL

    MDR report key: 412025 · Received August 20, 2002

    Report

    Report Number
    412025
    Event Type
    Malfunction
    Date Received
    August 20, 2002
    Date of Event
    August 14, 2002
    Report Date
    August 20, 2002
    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

    PREOPERATIVELY THE PT PRESENTED WITH AN ULCER ON THEIR LEFT CHEST WHICH EXPOSED THEIR BREAST IMPLANT AND THE LEFT IMPLANT WAS RUPTURED. PT HAD UNDERWENT BREAST AUGMENTATION IN 1979. THE RIGHT AND LEFT IMPLANTS WERE SURGICALLY REMOVED IN 2002. NO REPLACEMENT OF THE IMPLANTS WAS INDICATED AS THE PT DESIRED NO IMPLANTS TO BE REPLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other