BEUDAMED
    FDA Adverse Event Other Summary report: N

    MENTOR

    MDR report key: 555252 · Received September 17, 2004

    Report

    Report Number
    MW1033270
    Event Type
    Other
    Date Received
    September 17, 2004
    Date of Event
    September 13, 2004
    Report Date
    September 17, 2004
    Manufacturer
    MENTOR
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT IN VERY SERIIOUS MOTORCYCLE ACCIDENT IN 2004. THEY SUFFERED MULTIPLE RIB FRACTURES AND SIGNIFICANT TRAUMA FROM THE MULTIPLE RIB FRACTURES. CHANGE WAS NOTICED IN THE BREAST IMPLANTS. PT WAS ADMITTED TO HOSP FOR REMOVAL AND REPLACEMENT OF BREAST IMPLANTS THOUGHT TO BE RUPTURED. PT ALSO HAD CAPSULECTOMIES DONE. IT WAS NOTED DURING SURGERY THAT BOTH RIGHT AND LEFT BREAST IMPLANTS WERE RUPTURED. SURGEON IDENTIFIED BREAST IMPLANTS AS SILTEX MENTOR, SIZE 250 GEL IMPLANT. THESE IMPLANTS HAD BEEN PLACED IN 1996.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR BILATERAL SILTEX 250 GEL BREAST IMPLANTS FTR MENTOR UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other