BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILASTIC II MMRY G/S LPR 150/190

    MDR report key: 215492 · Received March 22, 1999

    Report

    Report Number
    1816403-1999-00123
    Event Type
    Injury
    Date Received
    March 22, 1999
    Report Date
    March 20, 1991
    Manufacturer
    DOW CORNING CORP.
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    OPERATIVE REPORT SHOWS PATIENT HAD PAINFUL HARD BREAST CAPSULES AND OPEN CAPSULECTOMIES WERE PERFORMED. OPERATIVE REPORT ALSO STATES PATIENT'S LEFT IMPLANT WAS DEFECTIVE; THEREFORE, SHE HAD REMOVAL AND REPLACEMENT OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILASTIC II MMRY G/S LPR 150/190 Implant MAM IMP GEL-SALINE FTR DOW CORNING CORP. P0340150 HH128654

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other