BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILTEX LOW BLEED GEL-FILLED MAMMARY PROSTHESIS

    MDR report key: 185500 · Received August 31, 1998

    Report

    Report Number
    1645337-1998-00164
    Event Type
    Injury
    Date Received
    August 31, 1998
    Date of Event
    May 28, 1998
    Report Date
    August 21, 1998
    Manufacturer
    MENTOR
    Product Code
    FTR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A SILTEX LOW BLEED GEL-FILLED MAMMARY PROSTHESIS ON 01/18/1994. SUBSEQUENTLY, THE PATIENT EXPERIENCED A RUPTURE OF THE DEVICE, CAPSULAR CONTRACTURE AND PAIN. THE DEVICE WAS EXPLANTED ON 08/20/1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILTEX LOW BLEED GEL-FILLED MAMMARY PROSTHESIS Implant MAMMARY PROSTHESIS FTR MENTOR NA 78640

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention