BEUDAMED
    FDA Adverse Event Summary report: N

    SILICONE GEL IMPLANTS

    MDR report key: 2534377 · Received January 29, 2009

    Report

    Report Number
    2534377
    Date Received
    January 29, 2009
    Date of Event
    January 12, 2009
    Report Date
    January 29, 2009
    Manufacturer
    NA
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED WITH BILATERAL RUPTURED SILICONE GEL IMPLANTS WITH CAPSULAR CONTRACTURE. ORIGINAL BREAST AUGMENTATION DONE IN 1989. ON (B)(6) 2009, PT HAD REMOVAL OF BILATERAL RUPTURED SILICONE GEL IMPLANTS. BILATERAL CAPSULECTOMIES. BILATERAL BREAST AUGMENTATION WITH MASTOPEXY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE GEL IMPLANTS FTR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other IMPLANTS SENT TO PATHOLOGY.