BEUDAMED
    FDA Adverse Event Death Summary report: N

    SILTEX LOW BLEED GEL

    MDR report key: 305548 · Received November 16, 2000

    Report

    Report Number
    1645337-2000-00013
    Event Type
    Death
    Date Received
    November 16, 2000
    Date of Event
    July 9, 2000
    Report Date
    October 19, 2000
    Manufacturer
    MENTOR
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH BILATERAL SILTEX LOW BLEED GEL-FILLED MAMMARY PROSTHESES IN 2000 FOR RECONSTRUCTION OF THEIR BREASTS. IN 2000, THE PT DEVELOPED AN INFECTION. CULTURE RESULTS WERE POSITIVE FOR STAPH AUREUS. THE DEVICES WERE REMOVED IN 2000. THE PT LATER DIED IN 2000 DUE TO SEPTIC SHOCK (TOXIC SHOCK SYNDROME) AND MULTIPLE ORGAN FAILURE.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH BILATERAL SILTEX LOW BLEED GEL-FILLED MAMMARY PROSTHESES IN 2000 FOR AUGMENTATION (NOT RECONSTRUCTION AS PREVIOUSLY REPORTED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILTEX LOW BLEED GEL MAMMARY PROSTHESIS FTR MENTOR * 186538

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death